[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,295,0,25,[9,44,76,119,149,183,207,231,254,276,302,323,344,370,391,420,439,461,491,512,540,574,596,616,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100641768","olfactory-function-and-model-based-behavior-in-people-living-with-hiv-and-sud-100641768",false,"NCT07637669","Olfactory Function and Model-Based Behavior in People Living With HIV and SUD","Olfactory Function and Model-based Behavior in People Living With HIV and SUD","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nFor all participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Aged 18-65 years old. Justification: prevalence of olfactory impairments increases with age; after age 53, the prevalence is 24.5 percent, increasing to 62.5 percent in people ages 80-97.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nFor participants in the HIV+ and SUD+ and HIV+ and SUD- groups:\n\n-HIV positive.\n\nFor participants in the HIV+ and SUD+ and HIV- \\& SUD+ groups:\n\n-Substance Use Disorder (SUD) other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nFor all participants:\n\n* History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, central nervous system (CNS) tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.\n* History of current (past 12 months) uncontrolled major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD.\n* Candidates who recently (12 hours prior to a study visit) used medications and\u002For substances that are psychoactive or otherwise affect alertness will have to pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI\u002FPI judgment, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled.\n* History of clinically significant anaphylaxis, e.g., due to severe asthma or food and nonfood allergies (e.g., latex, detergents, soap, etc.). The MAI will retain discretion to exclude a participant based on this criterion.\n* Uncorrected impairments in visual acuity.\n* Non-English speaking. Justification: The data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English.\n* Pregnancy.\n* Any other condition that in the judgment of the investigators is incompatible with participation.\n\nFor participants in the HIV+ and SUD- and HIV- and SUD- groups:\n\n* History of current (past 12 months) SUD, excluding tobacco use disorder.\n* Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n* Daily alcohol or drug use (excluding caffeine and nicotine) for at least 4 continuous weeks in the past 12 months.\n\nFor participants in the HIV- and SU+ and HIV- and SUD- groups:\n\n-HIV positive.\n\nFor the Optional MRI Segment:\n\n-Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.","ALL","18 Years","65 Years",{"count":21,"type":22},120,"ESTIMATED","OBSERVATIONAL","Background:\n\nHuman immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell. HIV infection is common in people with substance use disorder (SUD). SUD also affects thinking ability. Researchers want to learn more about the connection between the sense of smell and decision-making ability in people with HIV, SUD, or both.\n\nObjective:\n\nTo test the sense of smell in people with HIV and\u002For SUD and how they make choices based on odors.\n\nEligibility:\n\nPeople aged 18 to 65 years with any of these: (1) HIV, (2) SUD, (3) both HIV and SUD, or (4) neither SUD nor HIV.\n\nDesign:\n\nParticipants will have 2 visits. Each visit will last 3 to 5 hours.\n\nIn visit 1, participants will have a blood draw and a saliva swab. They will answer questions about their health, sleep habits, food intake, and substance use. They will have smell tests:\n\nThey will smell scented sticks and answer questions about them. They will be blindfolded for some tests.\n\nThey will perform tasks on a computer. They will look at pictures and smell pleasant food odors, such as chocolate cake or pizza. Smells will be delivered using a nasal mask. Their sniffing and breathing will be measured. They may also be exposed to odor-free air. They will eat food that corresponds to one of the food odors they smelled.\n\nIn visit 2, participants will do a saliva swab and a different computer task that involves odors. They will also have tests of their attention and memory. Participants may opt to have an imaging scan of the brain.",[26,27],"HIV","Substance Use Disorder",[26,27,29,30],"Olfaction","Decision Making","NOT_YET_RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":22},"2026-08-26",{"date":39,"type":22},"2031-06-27",{"name":41,"class":42},"National Institute on Drug Abuse (NIDA)","NIH",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100610326","the-effects-of-cognitive-behavioral-therapy-on-insulin-resistance-in-people-with-hiv-100610326","NCT07226128","The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV","A Randomized, Controlled Trial Assessing the Effects of Cognitive Behavioral Therapy to Prevent Worsening Insulin Resistance in Depressed, Virologically-Suppressed, Antiretroviral-Treated Adults With HIV","Inclusion Criteria:\n\n* HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.\n* Age ≥ 18 years.\n* Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening\n* Meets the depression definition for this trial:\n\n  * (1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND\n  * (2) PHQ-9 depressive disorder diagnosis (2 or more of the 9 depressive symptoms, including depressed mood or anhedonia, present in the past 2 weeks), AND\n  * (3) functional impairment (using the tenth PHQ-9 item assessing social\u002Foccupational impairment), AND\n  * (4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND\n  * (5) no bipolar or psychotic disorders\n\nNOTE: The use of antidepressant medications is not exclusionary.\n\n* HbA1c \\\u003C 6.5% at Screening\n* HIV-1 RNA level \\\u003C 75 copies\u002FmL at Screening\n\nNOTE: There are no CD4 cell count eligibility criteria for this trial.\n\nExclusion Criteria:\n\n* Inability to complete written, informed consent\n* Inability to read and understand English as seen on a computer screen\n* Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%\n* History of bipolar disorder or a psychotic disorder, including schizophrenia\n\nNOTE: Depressive disorders are not exclusionary.\n\n* Incarceration at the time of any study visit\n* Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).\n* Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).\n\nNOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation\n\n* End stage renal disease requiring renal replacement therapy (dialysis, transplantation).\n* Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.\n\nNOTE: Localized treatment for skin cancers is not exclusionary.\n\n• Therapy for serious medical illnesses within 14 days prior to the Entry Visit\n\nNOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.\n\n* Pregnancy or breastfeeding during the study.\n* Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit\n\nNOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled\u002Fnasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors\n\nNOTE: Use of NSAIDS and aspirin are allowed\n\n• Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.",{"count":52,"type":22},150,"INTERVENTIONAL",[55],"NA","The goal of this clinical trial is to learn if depression treatment improves insulin resistance, or how the body uses insulin to lower blood sugar, in people with HIV on HIV treatment. Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the online group, participants will undergo 9 weekly treatment sessions. The education group will receive learning materials about depression and will be monitored every month. All participants will have 4 study visits over 12 months.",[26,58,59,60],"Depression in Adults","Insulin Resistance","Cognitive Behavior Therapy",[62,63,64,65,66],"hiv","depression","insulin resistance","diabetes","cognitive behavioral therapy","RECRUITING",{"date":34,"type":35},{"date":70,"type":35},"2026-04-10",{"date":72,"type":22},"2029-08-31",{"name":74,"class":75},"Indiana University","OTHER",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":53,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100629566","phase-4-reinitiation-of-antiretroviral-therapy-using-oral-bictegravir-emtricitabine-and-tenofovir-alafenamide-100629566","NCT07476339","REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE","A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B\u002FF\u002FTAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks","REINITIATE","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing the informed consent form (ICF)\n* Diagnosis of HIV-1 confirmed by any positive HIV 4th generation test or detectable HIV-1 RNA level in \\>6 months\n* Previously received ART for ≥30 consecutive days, as self-reported\n* No ART dose received for ≥12 weeks prior to provision of informed consent, by any route of administration (i.e., injection or oral), as self-reported\n* Returning to care with an interest to restart ART therapy\n* Body weight ≥55.12lbs (25 kg)\n* Signed ICF as described in the protocol which includes compliance with the requirements and restrictions listed in ICF and study protocol\n\nExclusion Criteria:\n\n* Diagnosis of HIV-2 infection\n* Known or suspected history of severe hepatic impairment (Child-Pugh Class C)\n* Known or suspected history of severe renal impairment (estimated creatinine clearance \\[eCrCl\\] \\\u003C30 mL\u002Fmin)\n* Concomitant medication that is contraindicated with B\u002FF\u002FTAF\n* Known or suspected resistance to BIC (resistance-associated mutations \\[RAMs\\] include: G118R, Y143C\u002FH\u002FR, Q148H\u002FK\u002FR, N155H\u002FS, or R263K in the integrase gene)\n* Known\u002Fsuspected resistance to tenofovir (TFV) (RAMs include: K65R\u002FE\u002FN, or K70E)\n* Known\u002Fsuspected history of 3 or more thymidine analog mutation (TAMs) (M41L, D67N, K70R, L210W, T215F\u002FY, and K219Q\u002FE\u002FN\u002FR), T69-insertions, or K65R\u002FE\u002FN in reverse transcriptase (RT)\n* History of B\u002FF\u002FTAF intolerance\n* Unable to swallow whole tablets or swallow tablets cut into halves\n* Unable to communicate in either English or Spanish",{"count":85,"type":22},200,[87],"PHASE4","Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.\n\nThe REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B\u002FF\u002FTAF on the same day that they return to care. B\u002FF\u002FTAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.\n\nResearchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.",[90,91,26,92],"HIV -1 Infection","HIV (Human Immunodeficiency Virus)","HIV 1 Infection",[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"HIV-1","HIV Infections","Bictegravir","Emtricitabine","Tenofovir Alafenamide","Antiretroviral Therapy","Antiretroviral Therapy, Highly Active","Treatment Interruption","Virologically Suppressed","Treatment-Experienced","Returning to Care","Phase 4","B\u002FF\u002FTAF","B\u002FF\u002FTAF; bictegravir, emtricitabine, tenofovir alafenamide, drug combination","Rapid Restart","2026-08-18",{"date":111,"type":35},"2026-08-19",{"date":113,"type":35},"2026-06-17",{"date":115,"type":22},"2027-06-17",{"name":117,"class":75},"CAN Community Health",10,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":126,"targetDuration":4,"studyType":53,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":43},"100578004","multi-interventional-approaches-to-mitigate-hiv-reservoirs-for-the-sustained-hiv-remission-without-antiretrovirals-100578004","NCT06805656","Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals","Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Use of Antiretrovirals","Inclusion Criteria:\n\n\\- \\> 18 years old \\\u003C 65 years old Documented HIV-1 infection. Has voluntarily signed ICF. On HAART ≥ 2 years, without changes in the 24 weeks immediately prior to screening.\n\nHIV viral load \\\u003C50 copies\u002FmL, and never \\> 50 copies\u002FmL on 2 consecutive occasions in the last 2 years. CD4 count nadir.\n\n\\> 350 cells\u002F mm3 Current CD4 count \\> 500 cells\u002F mm3. R5 HIV-1 at Screening as defined by proviral DNA genotropism.\n\nExclusion Criteria:\n\n\\- Any evidence of an active AIDS-defining condition. Any significant acute medical illness in the past 8 weeks. Women who are pregnant or breastfeeding. Use of any of the following within 90 days prior to entry: systemic cytotoxic chemotherapy; investigational agents; immunomodulators (colonystimulating factors, growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons); coumadin, warfarin, or other coumadin derivative anticoagulants. Use of an agent definitely or possibly associated with effects on QT intervals: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.\n\nReceipt of compounds with HDAC inhibitor-like activity, such as valproic acid or nicotinamide within the last 30 days. Potential participants may enroll after a 30-day washout period.\n\nKnown hypersensitivity to the components of gold salt, nicotinamide or its analogs.\n\nHepatitis B (HBsAg +) or Hepatitis C (HCV RNA +) infection. Known renal insufficiency defined as calculated creatinine clearance (Cockcroft Gault formula) \\\u003C60 mL\u002Fmin.\n\nSubjects with a laboratory abnormality grade 3 or 4 with the following exceptions: pancreatic amylase, cholesterol, triglyceride, gamma glutamyl transpeptidase, bilirubin.\n\nAny condition which, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.",{"count":127,"type":22},70,[129],"PHASE2","A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment achieved unprecedented results in the reduction of HIV DNA present in these cells and in the reduction of CD4 + and CD8 + T cell activation. Combined interventions include intensified antiretroviral treatment to mitigate residual HIV replication, use of a histone deacetylase inhibitor to interrupt viral latency, use of an anti-proliferative medication to reduce long-lived T cells that harbor HIV and a personalized dendritic cell therapy vaccine to eliminate cells with latent HIV infection or cells present in viral sanctuaries. Due to the good results obtained in the exploratory stage of the project, the investigators propose to expand it by recruiting a larger number of patients to confirm the previously obtained results and to generate new insights related to the mechanisms involved in viral latency, latency disruption and the effects of analytical treatment interruption of antiretrovirals among patients undergoing all above mentioned interventions.",[132,133],"Hiv","HIV I Infection",[135,136,137,138,139,140,141],"Dendritic Cell vaccination","antiretroviral intensification","Auranofin","Histone Deacetylase Inhibitor","residual viral replication","HIV sanctuaries","HIV latency",{"date":111,"type":35},{"date":144,"type":35},"2026-07-15",{"date":146,"type":22},"2028-06-01",{"name":148,"class":75},"Federal University of São Paulo",{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":156,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":53,"phases":160,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":43},"100652138","project-space-a-micro-randomized-trial-of-daily-text-messages-to-reduce-alcohol-use-and-hiv-risk-behavior-100652138","NCT07769580","Project SPACE: Testing Daily Text Messages to Reduce Alcohol Use and HIV Risk Behavior","Project SPACE (Study Pilot on Alcohol Construals Everyday)","Inclusion Criteria:\n\n* Male sex at birth and currently identify with male gender\n* Own and use a smartphone that can receive text messages daily\n* Have tested negative for HIV in the past 24 months\n* Be willing to consider a change in their drinking behavior\n* Not currently in a sexually exclusive relationship\n* In the past three months, the subject must have had at least 3 condomless sexual encounters with men and consumes ≥5 standard alcoholic drinks at least once a week.\n\nExclusion Criteria:\n\n* Involved in previous Project SPACE research (i.e., members of the Phase 1 community advisory board or Phase 2 pilot tests)\n* Participants that have sought treatment for substance use in the past month.","MALE","30 Years",{"count":159,"type":22},240,[55],"Project SPACE is a micro-randomized trial evaluating the proximal effects theory-based text messages on alcohol use and sexual HIV risk behaviors among HIV-negative young adult men at the day-level.\n\nAt baseline, all participants will complete GamePlan, an existing brief online sexual health program. During the subsequent 8-week intervention period, participants will complete a brief morning assessment of the preceding day and will be randomized each afternoon, with equal probability, to receive concrete (\"how\"), abstract (\"why\"), neutral control, or no afternoon intervention messages. Participants will also complete pre- and post-intervention measures. The effects of GamePlan are not being separately evaluated in this study.",[26,163,164],"Risk Behavior","Alcohol Abuse",[166,167,168,169,170,171,172,173,174],"Men who have sex with men","Micro-randomized trial","Construal level theory","Text messaging","Mobile health","Alcohol use","HIV prevention","Young adults","Intervention optimization","2026-08-17",{"date":111,"type":35},{"date":178,"type":22},"2027-02",{"date":180,"type":22},"2027-12",{"name":182,"class":75},"Emory University",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":189,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":53,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":43},"100581445","evaluation-of-a-novel-optical-microscope-with-a-deep-depth-of-field-deepdof-to-provide-histologic-quality-images-on-cervical-biopsies-and-loop-electrosurgical-excision-procedure-leep-specimens-at-the-point-of-care-100581445","NCT06850402","Evaluation of a Novel Optical Microscope With a Deep Depth of Field (DeepDOF) to Provide Histologic-quality Images on Cervical Biopsies and Loop Electrosurgical Excision Procedure (LEEP) Specimens at the Point-of-care","Inclusion Criteria:\n\n1. Women aged 25 - 49 years\n2. women undergoing cervical biopsy and\u002For LEEP\n3. Women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment)\n4. Willing and capable of providing informed consent\n\nExclusion Criteria:\n\n1. Women under 25 or over 49 years of age\n2. Women not undergoing cervical biopsy or LEEP\n3. Women who are pregnant","FEMALE","25 Years","49 Years",{"count":193,"type":22},400,[55],"All patients will be enrolled in Mozambique and Brazil. They will provide informed consent to use their cervical biopsy and\u002For LEEP specimens for imaging with DeepDOF prior to sending for standard of care processing and interpretation.",[197,26],"Cervical Cancer",[199],"HPV DNA Testing",{"date":109,"type":35},{"date":202,"type":35},"2025-09-22",{"date":204,"type":22},"2028-09-01",{"name":206,"class":75},"M.D. Anderson Cancer Center",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":4,"leadSponsor":229,"locationsCount":43},"100060283","leukapheresis-to-obtain-plasma-or-lymphocytes-for-studies-of-hiv-infected-patients-including-long-term-non-progressors-100060283","NCT00029445","Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors","Evaluation of Viral Factors and Immune Parameters to Study HIV-Specific Immunity","* INCLUSION CRITERIA:\n\n  1. Adult (18 years-old or older)\n  2. Eligibility to undergo apheresis procedures; or, for participants who are unable to undergo apheresis, willingness to undergo blood draw for research purposes that remain within safety guidelines established by NIH policy.\n  3. Willingness to give informed consent for the storage of blood or tissue samples and HLA testing\n\nAND at least one of the following:\n\n* An HIV-seropositive participant categorized as an LTNP as defined by clinical and laboratory criteria, regardless of HLA class I type.\n* HIV-seropositive progressors\n* Persons who are seronegative for HIV but are family members of seropositive participants exhibiting immunologic control of HIV\n\nEXCLUSION CRITERIA:\n\n1. Pregnant\n2. Cardiovascular instability, severe anemia, inadequate venous access, severe coagulation disorder, or any other condition that the Principal Investigator or Apheresis Unit staff considers a contraindication to the apheresis procedure or research blood draw.\n3. Any condition that, in the opinion of the investigator, contraindicates participation in this study.","100 Years",{"count":216,"type":22},500,"This study will collect white blood cells and plasma for research on how the immune system controls HIV infection. The immune system of a very small group of people with HIV, called non-progressors, has been able to control HIV for long periods without antiretroviral therapy. Some immune system-related genes important for this control have been identified in these patients.\n\nPeople living with HIV who are 18 years of age and older, documented or suspected long-term nonprogressors in generally good health may be eligible to screen for the study.\n\nParticipants will undergo apheresis (a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw) if venous access is adequate once yearly. Some may be asked to return every six months.\n\n* Automated apheresis - Blood is drawn through a needle placed in an arm vein and spun in a machine, separating the blood components. The white cells are extracted and the red cells, with or without plasma (liquid part of the blood), are re-infused into the donor through a needle in the other arm. An anticoagulant (medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during processing.\n* Blood draw - a needle placed in an arm vein for large volume (approx 75ml) blood draw if veins considered inadequate for apheresis procedure.\n\nSome of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing, a genetic test of markers of the immune system.\n\n...",[26],[220,221,222,223,224],"Natural History","Long-term nonprogressors","HLA B*5701","Apheresis","HIV Infection","2026-08-15",{"date":109,"type":35},{"date":228,"type":35},"2001-08-09",{"name":230,"class":42},"National Institute of Allergy and Infectious Diseases (NIAID)",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":237,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":4,"leadSponsor":252,"locationsCount":253},"100054343","studies-of-the-pathogenesis-of-hiv-infection-in-human-peripheral-blood-cells-andor-body-fluids-in-people-living-with-and-without-hiv-100054343","NCT00001281","Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and\u002For Body Fluids in People Living With and Without HIV","* INCLUSION CRITERIA:\n* 18 years of age or older.\n* Adequate venous access.\n* Have a blood pressure less than or equal to 180\u002F100: pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer.\n* Have adequate blood counts (volunteers living with HIV: hemoglobin greater than or equal to 9.0 g\u002FdL, platelets greater than or equal to 50,000; volunteers living without HIV: hemoglobin greater than or equal to 9.0 g\u002FdL, platelets greater than or equal to 50,000\n* Be willing and able to provide written informed consent on screening, comply with study requirements and procedures, and comply with clinic policies\n* Willingness to allow blood samples to be used for future studies of HIV infection\u002Fpathogenesis, and undergo hepatitis screening\n\nEXCLUSION CRITERIA:\n\n* Pregnant and\u002For breastfeeding females.\n* Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise volunteer safety.",true,"120 Years",{"count":240,"type":22},2419,"We are studying virologic and\u002For immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of HIV. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model....",[26,243,244],"Immunodeficiencies","Infectious Diseases",[246,247,248,220],"Lymphocytes","Venipuncture","Mononuclear Cells",{"date":109,"type":35},{"date":251,"type":35},"1993-03-09",{"name":230,"class":42},2,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":237,"sex":17,"minAge":18,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":53,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":253},"100609031","phase-2-baricitinib-curative-repression-of-hiv-1-100609031","NCT07209267","Baricitinib Curative Repression of HIV-1","Inclusion Criteria:\n\n* Documented HIV infection\n* On continuous ART for at least 96 weeks before enrollment, with no interruption of ART for 7 consecutive days or longer in the 48 weeks before enrollment.\n* Plasma HIV-1 RNA levels of \\\u003C50 copies\u002FmL for at least 96 weeks (a minimum of two measures), and \\\u003C50 copies\u002FmL for a sample obtained within 90 days before enrollment.\n* CD4+ T-cell count ≥500 cells\u002Fmm3 obtained within 90 days prior to enrollment\n* No known history of CD4+ T-cell count nadir \\\u003C200 cells\u002Fmm3\n* Negative pregnancy test at time of study enrollment\n* Additional laboratory criteria apply.\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age or \\> 70 years of age\n* Pregnancy or breastfeeding, as determined by a blood pregnancy test\n* History of AIDS-defining illness, except for recurrent pneumonia.\n* History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.\n* Untreated latent tuberculosis infection (which will be screened for before entry). If there is a prior positive test, the test does not need to be repeated at screening.\n* History of use of any immunomodulatory medications within 6 months before enrollment, including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immunomodulatory effect.\n* History of deep venous thrombosis\n* Cardiovascular disease (Coronary artery disease or history of myocardial infarction, Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines, history of stroke)\n* History of HIV-associated malignancy, including Kaposi's sarcoma, or any lymphoma\u002Fleukemia or virus-associated cancers. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months\n* Major surgery within 8 weeks before screening, or will require major surgery during the study\n* Current or recent (\\\u003C4 weeks before screening) clinically serious viral (including COVID-19), bacterial, fungal, or parasitic infection or any other active or recent infection. History of untreated syphilis infection. If a rapid plasma reagin (RPR) test was negative in the 3 months before screening, then an RPR is not needed at screening\n* Symptomatic herpes simplex at the time of screening.\n* Symptomatic herpes zoster infection within 12 weeks before screening.\n* History of disseminated\u002Fcomplicated herpes zoster (for example, ophthalmic zoster or central nervous system (CNS) involvement).\n* Positive test for hepatitis B virus (HBV)\n* Additional exclusion criteria apply","70 Years",{"count":262,"type":22},35,[129],"This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.",[224,26],[267,268],"Baricitinib","Antiretroviral Therapy (ART)","2026-08-14",{"date":175,"type":35},{"date":272,"type":22},"2026-10",{"date":274,"type":22},"2028-01",{"name":182,"class":75},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":237,"sex":17,"minAge":283,"maxAge":238,"enrollmentInfo":284,"targetDuration":4,"studyType":53,"phases":286,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":43},"100475404","phase-1-trial-of-allogeneic-reduced-intensity-hla-haploidentical-allogeneic-hematopoietic-cell-bone-marrow-transplantation-followed-by-graft-versus-host-disease-gvhd-prophylaxis-with-cyclophosphamide-bortezomib-and-maraviroc-for-hematologic-malignancies--100475404","NCT05470491","Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...","A Phase I\u002FII Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Transplantation Followed by GVHD Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV (PLWH)","* INCLUSION CRITERIA - RECIPIENT:\n* Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:\n\n  * Acute myeloid leukemia in morphologic complete remission (\\\u003C5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)\n  * Any secondary and\u002For treatment related myeloid neoplasm with antecedent history of myeloid neoplasm or previous chemotherapy\u002Fradiation\n  * B-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * T-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)\n  * Primary myelofibrosis of intermediate-2 or higher risk by the Dynamic IPSS-Plus (DIPSS-Plus) or high to very high risk score (5 or higher) calculated with MIPSS70+ Calculator; DIPSS-Plus For Myeloproliferative Neoplasms on the Mutation Enhanced International Prognostic Score System (MIPSS70\u002FMIPSS70+)\n  * Chronic myelomonocytic leukemia\n  * Chronic myelogenous leukemia resistant to or intolerant of \\>=3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis\n  * B-cell lymphoma including Hodgkin lymphoma that has relapsed\u002Fprogressed within 1 year of completion of primary treatment, after autologous transplantation or has progressed through at least 2 lines of therapy\n  * Burkitt or lymphoblastic lymphoma: high-risk disease in first remission, progression\u002Frelapse after \\>=1 previous regimen\n  * Chronic lymphocytic leukemia with 17p deletion and\u002For unmutated IgHv or refractory or intolerant of both BTK and PI3K inhibitors\n  * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on published clinical practice guidelines\n  * T-Prolymphocytic leukemia progressing\u002Frelapsing after alemtuzumab and at least one other regimen\n  * B-Prolymphocytic leukemia progressing\u002Frelapsing after fludarabine and at least one other salvage regimen\n  * Hematologic malignancy of dendritic cell or histiocytic cell type\n  * Multiple myeloma that relapses after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD), relapses after autologous transplantation, or manifests as plasma cell leukemia\n\nIn addition to standard indications for HCT: Participant with a hematologic malignancy eligible for consolidation of first remission with autologous transplantation, if autologous transplantation is not accessible to the participant.\n\n* HIV seropositive, with ART regimen that, when stable for \\>4 weeks, is associated with an HIV viral load \\\u003C400 copies\u002FmL at screening evaluations. Subsequent changes to avoid\u002Foptimize drug interactions with study drugs or essential supportive care drugs may be made to the ART regimen at any time during the eligibility assessment period, as long as the eligibility criteria were met and the regimen change is expected, by the study team and involved consultants\u002Fpharmacy, to be similarly effective for HIV control. These changes to the ART regimen are not part of the study. If changes to the ART regimen are made during the eligibility period, HIV viral load will be rechecked at least 1 week after the change but prior to protocol treatment consent.\n\n  * Dose level 1: ART regimen must include maraviroc\n  * Dose level 2 and 3: ART regimen must not include maraviroc and there must be no history of maraviroc intolerance or resistance\n* Age \\>= 18 years\n* At least one potentially suitable HLA-haploidentical first degree or collateral related donor. Recipients with donor-specific anti-HLA antibodies (DSAs) to all potential donors must have at least one potential donor option where the DSA strength has a mean fluorescence intensity of \\\u003C 5000 and antibodies are not complement-fixing.\n* Karnofsky performance score \\>=50 percent.\n* Adequate organ function defined as possessing all of the following:\n\n  * Cardiac ejection fraction by 2D ECHO of \\>=40 percent\n  * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLco, adjusted for hemoglobin) all of \\>=40 percent predicted. If unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation \\>92 percent on room air.\n  * Total bilirubin \\\u003C=3.0 mg\u002FdL (unless due to Gilbert's or hemolysis), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \\\u003C= 5x the upper limit of normal, gamma glutamyl transferase (GGT) \\\u003C= 5x the upper limit of normal\n* Estimated serum creatinine clearance of \\>=50 mL\u002Fmin\u002F1.73m2 calculated using eGFR in the clinical lab\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Individuals of childbearing potential and those that can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-allo HCT.\n\nEXCLUSION CRITERIA - RECIPIENT:\n\n* Participants who are receiving any other investigational agents that cannot be discontinued\u002Fcompleted at least 2 weeks prior to the date of beginning conditioning.\n* Poorly controlled malignant indication for transplantation, defined as:\n\n  * Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \\>5 percent or active extramedullary disease)\n  * Lymphoma not having demonstrated some degree of treatment sensitivity (chemosensitivity, radiosensitivity) by clinical and\u002For radiologic assessment\n  * Multiple myeloma not in complete remission, as determined by negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \\\u003C= 5 percent plasma cells in the bone marrow.\n* Uncontrolled intercurrent illness that in the opinion of the PI would make it unsafe to proceed with transplantation.\n* Study team is unable to identify an adequate antiretroviral regimen to adequately suppress the HIV viral load \\\u003C400 copies\u002FmL that is compatible with study drugs\n* Pregnancy\n* For lactating potential participants: unwilling to discontinue lactation prior to the start of study treatment on day -14.\n* Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (eATG, steroids, cyclophosphamide, busulfan, pentostatin, maraviroc, bortezomib, plerixafor (dose level 3 only)) used in the study.\n* Lack of central access potential sufficient for transplant\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol and\u002For antiretroviral therapy\n* Grade 3-4 motor or sensory neuropathy per CTCAE version 5.0\n\nINCLUSION CRITERIA - RELATED DONOR:\n\n* Related donor (age \\>=12) deemed suitable and eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood and\u002For PBSC graft aliquotfor research. Related donors will be evaluated in accordance with existing institutional Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n* Ability of participant or parent\u002Flegal guardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA - RELATED DONOR:\n\n-Failure to qualify per institutional Standard Policies","12 Years",{"count":285,"type":22},265,[287,129],"PHASE1","Background:\n\nPeople living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.\n\nObjective:\n\nThis study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer.\n\nEligibility:\n\nPeople aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow.\n\nDesign:\n\nThe study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant.\n\nParticipants will be screened. Their diagnoses, organ function and eligibility will be confirmed.\n\nParticipants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it.\n\nParticipants will be in the hospital for 6 weeks or longer.\n\nThey will receive various drugs for 2 weeks to prep their body for the transplant.\n\nThe transplant cells will be administered through the catheter.\n\nParticipants will continue to receive drug treatments after the transplant.\n\nBlood transfusions may also be needed.\n\nParticipants will return 1-2 times per week for follow-up visits for 3 months after discharge.\n\nParticipants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.",[26,290],"Hematologic Malignancies",[292,293,294],"Hematopoietic Cell Transplant","HCT","Human Immunodeficiency Virus",{"date":175,"type":35},{"date":297,"type":35},"2023-01-26",{"date":299,"type":22},"2028-07-30",{"name":301,"class":42},"National Cancer Institute (NCI)",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":4,"leadSponsor":322,"locationsCount":43},"100061017","leukapheresis-procedures-to-obtain-plasma-and-lymphocytes-for-research-studies-on-antiretroviral-naive-hiv-1-research-participants-100061017","NCT00039689","Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants","* INCLUSION CRITERIA:\n\n  1. Adult (18 years old or older) with HIV-1.\n  2. Adequate venous access for research blood collection.\n  3. Positive HIV antibody immunoassay and a positive confirmatory HIV test (as defined by current CDC criteria). Tests may be done in our clinic or by an outside provider. For individuals with suspected early HIV-1, the following additional criteria may be used: HIV-1 RNA levels of \\>2,000 copies\u002Fml with a negative result from an HIV antibody immunoassay.\n  4. Willingness to be able to make follow up visits at least once in the next 4 months and prior to the initiation of antiretroviral therapy (ART).\n  5. Blood pressure \\\u003C 180\u002F100; pulse rate between 50-100 unless a lower pulse rate is considered normal for the volunteer.\n  6. Adequate blood counts (hemoglobin greater than or equal to 9.0 g\u002FdL, hematocrit greater than or equal to 28 percent, platelets greaterhan or equal to 50,000).\n  7. Willingness and ability to give informed consent including consent for the storage of blood samples and genetic testing.\n  8. Antiretroviral naive, no antiretroviral use in the last six months, or previously enrolled 02-I-0202 participants on whom there are samples stored in the repository.\n\n     1. Participants who acquire HIV-1 while taking ART for pre-exposure prophylaxis will be eligible for enrollment as long as they meet diagnostic criteria for HIV positivity.\n     2. Participants who enroll under another LIR apheresis protocol within the past three months and complete the apheresis within 4 weeks of starting ART will also be eligible for enrollment.\n     3. Participants with limited (no more than 4 weeks before screening visit) recent use of ART may be eligible for study participation if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant and \u002F or breastfeeding.\n2. Be currently abusing alcohol or other drugs that potentially could interfere with the participant s compliance or safety.\n3. Have a condition which in the opinion of the investigators would make the participant ineligible for the study.",{"count":309,"type":22},750,"There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication and normalization of immune function, and natural killer function relative to HIV disease.\n\nStudy participants will be adult (older than 18 years) HIV primary or acutely affected patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease) and HIV chronically infected patients (those infected with HIV for longer than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women will not be enrolled in the study; women who become pregnant will be dropped from the study.\n\nLeukapheresis will be performed on each patient before HAART therapy begins and then three times a year. Each session will take between 1 and 3 hours.\n\nThis longitudinal study will enable researchers to examine the function of certain B cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART.",[26],[313,314,99,315,316,220,224,317,318],"Cellular Immunity","Chronic HIV Infection","Primary HIV Infection","Humoral Immunity","Acute Infection","Treatment Naive",{"date":175,"type":35},{"date":321,"type":35},"2002-07-12",{"name":230,"class":42},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":53,"phases":333,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":343},"100636695","phase-1-a-trial-to-evaluate-the-safety-and-tolerability-of-dv700p-rna-and-dv701b11-rna-immunization-in-combination-with-antiretroviral-analytical-treatment-interruption-ati-in-people-living-with-hiv-for-elicitation-of-v3-glycan-antibodies-100636695","NCT07569029","A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies","A Nonrandomized Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies","Inclusion Criteria:\n\n* Able and willing to provide informed consent.\n* Age 18 to 60 years.\n* Documented HIV infection.\n* Lowest (nadir) CD4+ count between 250 and 450 cells\u002Fmm³.\n* On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening.\n* Plasma HIV RNA \\\u003C50 copies\u002FmL for at least 48 weeks prior to enrollment, allowing limited transient increases.\n* CD4+ count \\>450 cells\u002Fmm³ and CD4+ percentage ≥15%.\n* Willing and able to comply with study visits and procedures.\n* Agrees not to participate in another investigational study during participation unless approved.\n* In general good health, with no clinically significant findings on physical exam or laboratory testing.\n* Hemoglobin ≥11.0 g\u002FdL (women) or ≥13.0 g\u002FdL (men).\n* Absolute neutrophil count ≥750\u002Fmm³.\n* Platelet count ≥100,000\u002Fmm³.\n* ALT \\\u003C2.5 × upper limit of normal.\n* Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m².\n* Serum creatinine ≤1.1 × upper limit of normal.\n* Serum calcium \\>8.5 mg\u002FdL.\n* Blood pressure within acceptable limits.\n* Agrees to use condoms during the specified period when ART is interrupted until HIV RNA is undetectable.\n* No evidence of active hepatitis C infection.\n* No evidence of active hepatitis B infection.\n* For individuals of pregnancy potential: negative pregnancy test prior to enrollment and agreement to use effective contraception during the required study period.\n* Agreement not to seek pregnancy during the required study period.\n\nExclusion Criteria:\n\n* Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs).\n* Use of long-acting ART within 3 months prior to enrollment.\n* Known resistance to any component of the current ART regimen (excluding M184V\u002FI mutation).\n* Resistance to one or more drugs in two or more ART classes (excluding M184V\u002FI mutation).\n* Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known).\n* History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count \\\u003C200 cells\u002Fmm³ within the past 10 years.\n* History of severe HIV-related conditions, including opportunistic infections, HIV-associated cancers, lymphoma, neurocognitive disease, or progressive multifocal leukoencephalopathy.\n* Active or recent non-HIV-related cancer requiring systemic treatment within 36 months or expected need for treatment within 12 months (excluding minor skin cancers).\n* Active hepatitis B or hepatitis C infection.\n* Significant liver disease, including cirrhosis or advanced fatty liver disease.\n* Untreated or incompletely treated active or latent tuberculosis.\n* Pregnancy or breastfeeding.\n* Body mass index (BMI) ≥40 kg\u002Fm², unless approved.\n* Diabetes mellitus, except well-controlled type 2 diabetes as allowed.\n* History of or current atherosclerotic cardiovascular disease, including heart attack, angina, stroke, or peripheral arterial disease.\n* Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed).\n* Receipt of a non-HIV investigational vaccine within 1 year, unless approved or licensed.\n* Conditions causing impaired immune function or use of immunosuppressive medications within the specified timeframe.\n* Prior receipt of anti-HIV monoclonal antibody therapy.\n* Receipt of certain vaccines within restricted timeframes prior to enrollment (including live or mRNA vaccines within 4 weeks).\n* Receipt of other vaccines within 14 days prior to enrollment.\n* History of myocarditis or pericarditis.\n* Recent initiation of allergy immunotherapy within 1 year (unless stable or approved).\n* Recent use of investigational agents within restricted timeframes prior to enrollment.\n* History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products.\n* History of angioedema.\n* Idiopathic urticaria within the past year.\n* Chronic urticaria or urticaria within the past year.\n* History of urticaria associated with vaccination.\n* Bleeding disorders or use of systemic anticoagulants.\n* Conditions associated with increased risk of clotting or bleeding.\n* History of seizures within the past 3 years or use of anti-seizure medications within that period.\n* Absence of spleen or impaired splenic function.\n* Active duty or reserve military personnel (U.S.).\n* Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation.\n* Uncontrolled or severe asthma.\n* History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed.\n* Allergy to local anesthetics (e.g., lidocaine).\n* Difficulty with venous access that would interfere with study procedures.","60 Years",{"count":332,"type":22},42,[287],"This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.",[26],"2026-08-13",{"date":175,"type":35},{"date":339,"type":22},"2026-09-15",{"date":341,"type":22},"2027-08-31",{"name":230,"class":42},19,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":237,"sex":17,"minAge":352,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":53,"phases":355,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":43},"100611859","streamlining-telehealth-for-expanded-prep-utilization-through-community-partnerships-100611859","NCT07246057","Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships","Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships (STEP-UP)","STEP-UP","Inclusion -\n\nClient Interviews:\n\n1. At least 18 years of age or older\n2. Have received services or participated in programming at a partner CBO in the past 12 months\n3. Currently live in the Philadelphia metropolitan area\n4. Able to provide informed consent\n\nStaff Interviews:\n\n1. At least 18 years of age or older\n2. Currently employed at Philadelphia telePrEP Program or a partner CBO\n3. Serve in a client-facing role (e.g., outreach specialists) or leadership position (e.g., program coordinators) at one of the aforementioned organizations\n4. Have been in their current role for at least 6 months\n5. Able to provide informed consent\n\nClient Surveys:\n\n1. At least 16 years of age or older\n2. Have engaged with a Community TelePrEP Navigator through a partner site CBO to schedule a telehealth appointment with a PrEP provider\n3. Currently live in the Philadelphia metropolitan area\n4. Able to provide informed consent\n\nExclusion-\n\n1. Under 16 years of age (clients surveys) or under 18 years of age (staff interviews or client interviews)\n2. Do not currently live in the Philadelphia metropolitan area\n3. Unable to provide informed consent due to cognitive impairment or other factors\n4. Individuals who pose a safety risk to research staff or other participants\n5. Clients currently living with HIV","16 Years",{"count":354,"type":22},92,[55],"The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools. STEP-UP is an innovative model for PrEP delivery that positions community-based organizations (CBOs) as hubs for PrEP access. STEP-UP builds on the established trust, community expertise, and comprehensive services of CBOs serving individuals who could benefit from HIV prevention tools, integrating telehealth PrEP delivery into their existing infrastructure through partnership with a local telehealth PrEP program. By enabling CBOs to offer telePrEP navigation within their array of health and social services, STEP-UP creates accessible, comprehensive care centers that address barriers to PrEP access faced by individuals who could benefit from HIV prevention tools. The main questions it aims to answer are:\n\n1. Is STEP-UP acceptable and feasible to implement in community settings?\n2. Does STEP-UP increase PrEP prescription rates compared to the existing direct-to-consumer telehealth model?\n\nResearchers will compare people who receive telehealth PrEP services through STEP-UP at community-based organizations to those who access telehealth PrEP through the existing direct-to-consumer telehealth model. Some participants will:\n\n1. Complete surveys about their experiences with the program\n2. Participate in an interview to share their perspectives and feedback about the program.",[26],[359,360,361,362],"Pre-exposure prophylaxis","Telehealth","Community-based organizations","Implementation science",{"date":269,"type":35},{"date":365,"type":35},"2026-03-26",{"date":367,"type":22},"2028-07-15",{"name":369,"class":75},"University of Pennsylvania",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":214,"enrollmentInfo":376,"targetDuration":4,"studyType":53,"phases":378,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":43},"100471449","phase-2-imaging-and-biopsy-of-people-with-hiv-1-undergoing-analytic-treatment-interruption-100471449","NCT05419024","Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption","* INCLUSION CRITERIA:\n\nParticipants must meet all of the following criteria to be eligible for this study:\n\n1. Aged \\>=18 years.\n2. People with HIV-1 documented using US Food and Drug Administration-approved screening and confirmatory or supplemental assays in Centers for Disease Control and Prevention (CDC)-recommended testing strategies.\n3. Established medical care outside NIH.\n4. Able to provide informed consent.\n5. Willing to allow samples to be stored for future research.\n6. Willing to allow genetic testing.\n7. Undergoing cART using recommended, alternative, or other regimens as defined by \"Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.\"\n8. Viral RNA \\\u003C40 copies\u002FmL plasma by conventional assay for at least 3 years (blips \\[transient increases within 6 weeks\\] of \\\u003C200 copies\u002FmL are allowable when succeeding viral levels return to \\\u003C40 copies\u002FmL on subsequent testing).\n9. CD4 cell count \\>=350 cells\u002Fmicroliter.\n10. Willing to interrupt ART for up to 90 days.\n11. Willing to use a barrier method of contraception, such as condoms or dental dams, when engaging in sexual activity, or remain abstinent during ATI and after re-initiating ART until viral re-suppression is achieved, to prevent pregnancy and transmission of HIV.\n\nEXCLUSION CRITERIA:\n\nParticipants who meet any of the following criteria will be excluded from this study:\n\n1. Active intercurrent illness or infection, including fever \\>38 degrees Celsius.\n2. Known history of initiating ART during the first year of infection with HIV. Participants will be considered to have initiated ART within 1 year of infection as defined by documented screening\u002Fconfirmatory seroconversion (positive testing within one year of non-reactive HIV enzyme-linked immunosorbent assay).\n3. Pregnant.\n4. Breastfeeding.\n5. Currently undergoing therapy with drugs that, in the judgment of the investigators, may interfere with biodistribution of FDG, including prednisolone, valproate carbamazepine, phenytoin, phenobarbital, and catecholamines.\n6. Undergoing ART that is incompatible with an ATI.\n7. Has undergone PET\u002FCT within the last 6 months.\n8. History of poorly controlled diabetes that, in the judgement of the investigators, would prevent completion of PET\u002FCT scan.\n9. Vaccination within the previous 4 weeks.\n10. History of ATI within the past 1 year.\n11. Has comorbid illness for which, in the judgment of the investigators, an ATI will represent elevated risk.\n12. Active opportunistic infection as defined by the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.\n13. Significant active substance abuse or psychiatric illness that may, in the judgment of the investigator, interfere with study visits or procedures.\n14. Allergy to planned anesthetic agents that are expected to be used. For local anesthetics, this is lidocaine. For sedation, this is midazolam and fentanyl.\n15. Currently undergoing chronic systemic steroid therapy (corticosteroid nasal spray or inhaler, topical steroid use, and hormone replacement are acceptable).\n16. Contraindication to use of IV contrast.\n17. History of developing keloids.\n18. Renal impairment: HIV-related kidney disease or estimated glomerular filtration rate (eGFR) CKD-EPI equation \\\u003C60 mL\u002Fmin\u002F1.73 m\\^2. For individuals undergoing therapy with cobicistat or integrase strand inhibitors, GFR may be estimated using cystatin C or creatinine.\n19. Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both.\n20. Active hepatitis C virus infection, with detectable virus RNA.\n21. History of HIV-associated dementia or progressive multifocal leukoencephalopathy.\n22. Documented ARV drug resistance that, in the judgment of the investigator, would pose a risk of virologic failure should additional mutations develop during the study.\n23. History of cardiovascular event or at high risk of an event (e.g., atherosclerotic cardiovascular disease score \\>20%) by a currently accepted risk calculator such as the 2023 AHA Predicting Risk of Cardiovascular Disease Events (PREVENT) or the 2018 ASCVD Risk Estimator Plus.\n24. History of AIDS-defining illness according to CDC criteria within the past 3 years.\n25. Hepatic impairment: aminotransferase \\>2.5 x the upper limit of normal or documented history of cirrhosis.\n26. Any condition that, in the judgment of the investigator, contraindicates participation in this study.",{"count":377,"type":22},50,[129],"Background:\n\nHuman immunodeficiency virus (HIV) infects CD4 T cells. There is no cure for HIV. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection. ART stops HIV from infecting cells, but HIV does not go away. Some infected cells remain. If ART is stopped, then HIV levels will rise and infect more cells.\n\nObjective:\n\nTo compare changes in the amount of virus in blood and lymph nodes after a short treatment interruption.\n\nEligibility:\n\nAdults aged 18 years or older who are undergoing ART for HIV infection.\n\nDesign:\n\nParticipants will be screened with a physical exam, including blood tests. They will be assigned to 1 of 2 groups:\n\nOne group will stay on ART. They will have 2 study visits: the first 45 days after screening, and the second 12 to 16 weeks later. They will have a PET\u002FCT scan at each visit. A substance called a tracer will be injected into their arm. They will lie still on a table that moves through a doughnut-shaped machine. This process takes up to 2 hours.\n\nThe other group will stop ART for no more than 90 days. This group will have 3 PET\u002FCT scans over 8 months. Once they stop ART, they will visit the clinic weekly for blood tests. After restarting ART, they will continue to visit the clinic weekly until their HIV level is safe.\n\nAll participants will have small samples of tissue taken from lymph nodes. They may also opt to provide semen samples or vaginal fluid. They may have samples taken of bone marrow or the fluid inside their spinal column.",[26],[294,99,382,383],"FDG-PET","Reservoir","2026-08-12",{"date":336,"type":35},{"date":387,"type":35},"2023-01-09",{"date":389,"type":22},"2029-08-01",{"name":301,"class":42},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":53,"phases":401,"briefSummary":402,"conditions":403,"keywords":406,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":43},"100649452","reducing-stigma-and-building-employability-skills-for-young-people-with-hiv-in-zambia-100649452","NCT07732660","Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia","Kupambana: A Combined Microeconomic Strengthening and Stigma Reduction Intervention for Young People With HIV in Zambia","Inclusion Criteria:\n\n* Age 18 to 24 years\n* Confirmed HIV-positive status, verified using health records obtained from health facilities with participant consent\n* Residing in the Chipata, Katete, or Lundazi Districts of Zambia's Eastern Province\n* Currently receiving HIV treatment, or previously initiated but disengaged from HIV treatment (stratified purposive sampling will be used to enroll roughly equal proportions of youth currently in care and those who have dropped out of care)\n* Reports at least one indicator of economic vulnerability, defined as any of the following: unemployed or without a regular source of income; not attending school or post-secondary education; or individual income below Zambia's national poverty line\n\nExclusion Criteria:\n\n\\- HIV-negative or unknown status","24 Years",{"count":400,"type":22},100,[55],"The goal of this clinical trial is to learn if a program called Kupambana can improve mental health and HIV care outcomes in young people with HIV in Zambia by combining stigma-reduction support with financial and job-skills training. The main questions it aims to answer are whether Kupambana is feasible and acceptable to young people with HIV and whether it improves mental health, reduces stigma, and improves progress along the HIV care continuum, such as staying in care and taking HIV medicine as prescribed. Researchers will compare young people who participate in Kupambana with those who receive a one-time financial literacy training session (usual care) to determine whether Kupambana leads to greater improvements in stigma, mental health, and HIV care outcomes. Participants will complete a baseline questionnaire and then be randomly assigned to either the Kupambana program or the one-time financial literacy training. Those assigned to Kupambana will attend eight weekly peer-led support group sessions focused on reducing HIV- and poverty-related stigma, receive a voucher for technical and vocational education and training, and attend a one-time financial literacy session. Those assigned to the comparison group will attend only the one-time financial literacy session. All participants will complete follow-up surveys at the end of the program and again 3 and 6 months later.",[26,404,405],"Mental Health","Treatment Adherence",[95,407,408,409,410,411],"Social Stigma","Poverty","Young Adult","Zambia","Vocational Education","2026-08-11",{"date":384,"type":35},{"date":415,"type":22},"2026-09-03",{"date":417,"type":22},"2027-10",{"name":419,"class":75},"University of North Carolina, Chapel Hill",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":427,"targetDuration":4,"studyType":53,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100609608","phase-2-small-trial-of-alendronate-impact-on-the-reservoir-of-hiv-100609608","NCT07216794","Small Trial of Alendronate Impact on the Reservoir of HIV","STAIR-HIV","Inclusion Criteria:\n\n1. Participants must have a confirmed HIV-1 diagnosis. This can be shown by any approved rapid HIV test or HIV enzyme\u002Fchemiluminescence test done at any time before joining the study.\n2. The diagnosis must be confirmed by one of the following tests: a second different antibody test, quantitative or qualitative HIV-1 RNA PCR, HIV DNA PCR, HIV total nucleic acid test, HIV-1\u002F2 differentiation assay, or Western blot. All tests must use whole blood, serum, or plasma (not dried blood spots) and be FDA-approved if available.\n3. Participants must have been on ART for at least 1 year before joining the study, with no interruptions longer than 7 consecutive days in the past 48 weeks.\n4. Participants must have been on ART for no more than 10 years before joining the study.\n5. Participants should not plan to change their ART regimen during the study.\n6. Participants' CD4 cell count must be at least 350 cells\u002Fmm³, measured within 30 days before joining the study, at a certified laboratory.\n7. Participants' HIV-1 RNA levels must be below 50 copies\u002FmL for the past 48 weeks and for a sample taken within 30 days before joining the study, measured at a certified laboratory.\n8. Participants must have the following lab values within 30 days before joining the study, measured at a certified laboratory:\n\n   * White blood cells (WBC) ≥ 2,500 cells\u002Fmm³\n   * Absolute neutrophil count (ANC) \\> 1,000 cells\u002Fmm³\n   * Hemoglobin \\> 12 g\u002FdL for males and \\> 11.5 g\u002FdL for females\n   * Platelet count ≥ 125,000 cells\u002Fmm³\n   * Liver enzymes (AST, ALT, alkaline phosphatase) \\\u003C 1.5 times the upper limit of normal (ULN)\n   * Total bilirubin \\\u003C 1.5 times ULN\n   * Vitamin D level \\> 15 ng\u002FmL\n   * Estimated glomerular filtration rate (eGFR) ≥ 35 mL\u002Fmin\u002F1.73 m²\n   * Negative hepatitis B surface antigen (HBsAg)\n   * Negative hepatitis C antibody or RNA test\n   * Calcium level between 8.4 mg\u002FdL and 10.6 mg\u002FdL\n   * Phosphate level ≥ 3.4 mg\u002FdL\n9. If participants are women who could become pregnant, they must have a negative pregnancy test within 48 hours before joining the study. This test must be done at a certified clinic or laboratory.\n10. If participants are women who could become pregnant and are sexually active, they must agree to use two methods of contraception from 10 days before starting the study until the end of the study. One method must be highly effective (e.g., implant, IUD, oral contraceptives, injectable contraceptives, vaginal ring, contraceptive patch, or sterilization of male partner). The second method must be a barrier method (e.g., condoms, diaphragm, cervical cap, or sponge with spermicide).\n11. Participants must have a Karnofsky performance score of at least 70 within 90 days before joining the study.\n12. If participants are postmenopausal women or men aged 50 or older, they must have a DEXA scan within 2 years before joining the study to check for osteoporosis. If participants have severe bone thinning (osteopenia), they may need another DEXA scan before joining the study.\n13. Participants must be able to swallow pills without difficulty.\n\nExclusion Criteria:\n\n1. Participants who started antiretroviral therapy (ART) during the early stages of HIV infection.\n2. Male participants with low testosterone levels (below 250 ng\u002FdL) within 90 days before joining the study, or those with levels between 250-400 ng\u002FdL who plan to start testosterone replacement within 90 days before joining the study.\n3. Males with stable hypogonadism who have been on the same dose of testosterone treatment for at least 24 weeks can join if they don't plan to change their regimen during the study.\n4. Participants with current or past conditions that cause esophageal inflammation, ulcers, strictures, or swallowing disorders (e.g., Barrett's esophagus, scleroderma, esophageal strictures, achalasia, or other motility disorders).\n5. Participants with severe, uncontrolled reflux that might increase the risk of esophagitis, according to the site investigator.\n6. Participants who had esophagitis within the past year.\n7. Participants with a history of Paget's disease.\n8. Participants with a history of osteoporosis.\n9. Participants who had a bone fracture within the past 180 days.\n10. Participants who had one or more bone fractures not caused by trauma since age 18.\n11. Participants with diagnosed bleeding disorders or those currently taking anticoagulants or blood factor products.\n12. Participants who cannot stand up or sit upright for at least 30 minutes.\n13. Participants who used systemic glucocorticoids for more than 30 days within the past 180 days at doses higher than or equivalent to 7.5 mg prednisone\u002Fday or 30 mg hydrocortisone\u002Fday.\n14. Participants with active or recent cancer requiring chemotherapy, immunotherapy, or surgery within the past 36 months or expected to need such treatments in the next year.\n15. Participants with advanced liver disease (non-alcoholic fatty liver disease, steatohepatitis, or alcoholic liver disease) with known or suspected cirrhosis or fibrosis score ≥F3.\n16. Participants who had invasive dental procedures within the past 6 weeks or plan to have them within the next 40 weeks (regular dental cleanings are allowed).\n17. Participants with significant active periodontal or other pre-existing dental disease at the time of joining the study.\n18. Participants who are currently pregnant, breastfeeding, or planning to become pregnant during the study.\n19. Participants who used oral complementary or alternative medicines (herbal and homeopathic products) within the past 14 days.\n20. Participants who used bisphosphonates (oral or injectable) within the past 12 months.\n21. Participants with known allergies or sensitivities to ALN, the components of the tablet, or bisphosphonate compounds.\n22. Participants with active drug or alcohol use or dependence that would interfere with adherence to study requirements, according to the site investigator.\n23. Participants with acute or serious illness requiring systemic treatment and\u002For hospitalization within the past 90 days.\n24. Participants who received any investigational vaccine within the past 180 days or any vaccine within the past 14 days.\n25. Participants who received anti-HIV broadly neutralizing antibody therapy within the past 78 weeks.\n26. Participants who received a latency-reversing agent within the past 12 months, unless reviewed and approved by the A5428 Clinical Management Committee (CMC).",{"count":428,"type":22},30,[129],"This clinical trial is designed to test the effects of alendronate (ALN) on people living with HIV who are already receiving antiretroviral therapy (ART). Participants are randomly assigned in a 2:1 ratio to either receive alendronate or a placebo, and neither the participants nor the researchers know who is receiving the actual treatment. The goal is to see if alendronate can reduce the size and activity of the HIV-1 reservoir in these individuals.",[26],{"date":336,"type":35},{"date":434,"type":35},"2026-07-08",{"date":436,"type":22},"2027-05-21",{"name":230,"class":42},5,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":53,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100496608","ending-tobacco-use-through-interactive-tailored-messaging-for-cambodian-people-living-with-hivaids-100496608","NCT05746442","Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV\u002FAIDS","Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV\u002FAIDS (Project END-IT)","ProjectENDIT","Inclusion Criteria:\n\n* 1\\) being aged ≥18 years\n* 2\\) being HIV-positive\n* 3\\) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes\u002Fday)\n* 4\\) willing to set a date for a quit attempt within 2 weeks of study enrollment\n* 5\\) being able to provide written informed consent to participate\n* 6\\) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form\n\nExclusion Criteria:\n\n* 1\\) history of a medical condition that precludes use of nicotine replacement therapy\n* 2\\) physician\u002Fclinician deemed ineligible to participate based on medical or psychiatric condition\n* 3\\) enrolled in another cessation program or use of other cessation medications.",{"count":448,"type":22},800,[55],"The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.",[452,26],"Smoking Cessation",{"date":336,"type":35},{"date":455,"type":35},"2023-01-11",{"date":457,"type":22},"2027-09-30",{"name":459,"class":75},"H. Lee Moffitt Cancer Center and Research Institute",3,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":237,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":53,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":4},"100573510","implementation-science-to-enhance-hiv-testing-services-during-emergency-care-in-kenya-100573510","NCT06747221","Implementation Science to Enhance HIV Testing Services During Emergency Care in Kenya","HIV Enhanced Access Testing in Emergency Department Program Using a Systems Analysis and Improvement Approach (HEATED-SAIA) Cluster Randomized Trial","HEATED-SAIA","Facility Level (Quantitative De-identified Systems Data)\n\nInclusion Criteria:\n\n* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties\n* Have an active emergency department\n* Have HIV testing services either embedded in the emergency department or the facility.\n\nExclusion Criteria:\n\n* Private health facilities\n* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without an active emergency department\n* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without existing HIV testing services\n\nParticipant Level (Qualitative Data) Healthcare Personnel\n\nInclusion Criteria:\n\n* Personnel working at the departments of health in Kwale, Mombassa and Kilifi Counties\n* Personnel working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties\n* Age 18 years or greater\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Personnel not working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties\n* Age less than 18 years\n* Not able and willing to provide informed consent\n\nParticipant Level (Qualitative Data) ED-HTS Clients\n\nInclusion Criteria:\n\n* Patients receiving emergency care and engaged for ED-HTS at a Kenya public health facilities randomized to the intervention arm of the trial in Kwale, Mombassa and Kilifi Counties\n* Age 18 years or greater\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Not able and willing to provide informed consent",{"count":470,"type":22},184,[55],"There are \\~38 million people living with HIV (PLH), with the majority in low-and middle-income countries (LMICs), where the UNAIDS 95-95-95 HIV targets are at risk of not being achieved. Data show that incident infections are concentrated in sub-Saharan Africa and focused in difficult to reach populations. These harder to reach persons frequently also have higher-risk profiles for HIV, making them essential target populations to receive HIV Testing Services (HTS). Among target populations, men, adolescents and young adults (AYAs) aged 15-24 years, and persons from key populations (KPs) represent crucial groups to be reached. In Africa, Emergency Departments (ED) provide care to large numbers of persons that often do not otherwise access health services. Data from Africa show that those seeking emergency care have high burdens of HIV, and desire ED-HTS. As in higher-income countries, EDs in LMICs provide a strategic opportunity to deliver evidence-based HTS interventions to higher-risk persons. In Kenya one in five PLH are unaware of their status, less than half of men are reached for HIV testing at appropriate frequencies, AYAs account for 42% of new infections and KPs contribute to hyper-endemic transmission. To address this, Kenya national strategy calls for utilizing facilities-based care to deliver HTS for difficult to reach populations. However, while the guidelines include EDs as service delivery points, HTS during emergency care in Kenya is still evolving and the evidence-base on best practices is in early development. The HIV Enhanced Access Testing in Emergency Department (HEATED) program in Kenya was developed by a collaborative team led by PI Aluisio (K23AI145411). The HEATED program was derived using the Capability-Opportunity-Motivation Behavioral model to enhance delivery of HTS, through locally appropriate and pragmatic systems initiatives. HEATED program implementation significantly improved HIV testing for the overall ED population by 31%, while also significantly increasing testing for men, AYA and KP and was found to be acceptable by stakeholders. Although pilot evaluation of the HEATED program demonstrated improved HTS for target populations, more robust understanding of optimal implementation strategies in ED settings, impacts on linkage to HIV care outcomes, costing and maintenance data are needed to inform development of ED-HTS programming in Kenya. To address this, the current proposal will build upon the HEATED program by evaluating use of the Systems Analysis and Improvement Approach (SAIA) implementation strategy (HEATED-SAIA) to improve HTS in a cluster randomized trial in all Ministry of Health EDs in Kilifi, Mombasa and Kwale Counties of the Coast Region of Kenya. The Reach, Effectiveness, Adoption, Implementation and Maintenance framework with quantitative and qualitative data will be used in trial assessment. Building on the K23 pilot data and leveraging SAIA, the HEATED-SAIA program has substantial potential to improve HTS delivery by strategically and pragmatically engaging difficult to reach populations already interfacing with emergency health systems, while being acceptable and cost-effective.",[26],[26,475,476,477,478,479,480,481,482],"SAIA","Emergency Care","Africa","Kenya","Emergency Services","HIV Testing Services","Systems Analysis and Improvement Approach","Implementation Science","2026-08-10",{"date":384,"type":35},{"date":486,"type":22},"2027-02-01",{"date":488,"type":22},"2030-03-31",{"name":490,"class":75},"Rhode Island Hospital",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":498,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":53,"phases":501,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":43},"100651620","bridge-to-belonging-peer-led-intervention-to-reduce-loneliness-and-depression-among-older-gay-and-bisexual-men-100651620","NCT07762066","Bridge to Belonging: Peer Led Intervention to Reduce Loneliness and Depression Among Older Gay and Bisexual Men","B2B","Inclusion Criteria:\n\n* HIV+ and provide evidence or documentation of HIV+ status\n* Willing to release HIV-related health records\n* Self-identify as a man who has sex with men\n* Able to provide informed consent in English\n* Be ≥50 years old\n* Score at least a 2 on the PHQ-2 OR score at least a 4 on the UCLA Shortened Loneliness Scale\n\nExclusion Criteria:\n\n* HIV-\n* Does not self-identify as a man who has sex with men\n* Is less than 50 years old\n* Scores less than 2 on the PHQ-2 AND scores less than 4 on the UCLA Shortened Loneliness Scale","50 Years",{"count":500,"type":22},40,[55],"Older gay and bisexual men living with HIV (OGBMLH) are more likely to experience depression and loneliness, which can lead to negative health outcomes. This mixed-methods research study will assess the feasibility and acceptability of the Bridge to Belonging (B2B) intervention. B2B is a peer-delivered, manualized program designed to increase engagement in LGBTQ+-affirming elder services and thereby reduce loneliness and depression among OGBMLH. The program utilizes a) cognitive behavioral therapy-based Friendship Enrichment Program (FEP) to build social skills; b) Peer Mentoring (PM) to model and support engagement in community services; and c) connecting participants to affirming elder services such as meal programs, bereavement groups, social activities, etc. Interventions like B2B are essential to the NIH's goal of improving access to behavioral interventions through advances in HIV\u002FAIDS research.",[26],"2026-08-07",{"date":336,"type":35},{"date":507,"type":35},"2026-05-06",{"date":509,"type":22},"2026-12-01",{"name":511,"class":75},"Fenway Community Health",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":237,"sex":156,"minAge":18,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":53,"phases":522,"briefSummary":523,"conditions":524,"keywords":528,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":43},"100651615","gwan-enjoy-life-a-peer-supported-mental-health-mentoring-intervention-to-improve-engagement-in-care-among-sexual-minority-men-living-with-hiv-in-jamaica-100651615","NCT07762612","\"Gwan Enjoy Life:\" A Peer-Supported Mental Health Mentoring Intervention to Improve Engagement in Care Among Sexual Minority Men Living With HIV in Jamaica","\"Gwan Enjoy Life:\" Protocol for a Randomized Controlled Trial to Test a Peer-Supported Mental Health Intervention to Improve Engagement in Care for High-Priority Sexual Minority Men Living With HIV","GwanEnjoyLife","Inclusion Criteria:\n\n* Self-identified as a cisgender man who have sex with men\n* Age 18 and older,\n* Living in one of the 14 parishes\n* Able to offer informed consent\n* Living with HIV (currently engaged, marginally engaged, and not engaged in care)\n* Provide consent to clinic staff to review medical records.\n\nExclusion Criteria:\n\n* Self-reported participation in another HIV care engagement study\n* Unable to understand the consent process\n* Planning on relocating out of Jamaica over the next 12 months.",{"count":521,"type":22},60,[55],"Sexual minority men (SMM) in Jamaica face many challenges that affect their health and well-being. Although they make up a relatively small part of the population, they are much more likely to be living with HIV than the general public. Many also experience discrimination because of their sexual orientation, HIV-related stigma, violence, poverty, unstable housing, limited educational opportunities, and barriers created by laws and social attitudes. These experiences can have a serious impact on mental health, leading to problems such as depression, anxiety, trauma, and thoughts of suicide. Many people also face barriers to getting mental health care because of stigma or a lack of services that are welcoming and appropriate for their needs. These challenges can make it difficult for people living with HIV to stay connected to medical care and take their HIV medications consistently. Missing appointments or stopping treatment can make it harder to keep the virus under control and can lead to poorer health over time. While researchers know that stigma, discrimination, and violence affect health, we still do not fully understand how these experiences work together to influence HIV care among sexual minority men in Jamaica.\n\nTo help address these challenges, we developed the Gwan Enjoy Life program, a culturally relevant program designed specifically for sexual minority men living with HIV in Jamaica. The program combines practical coping skills, emotional support, and strategies for managing the effects of trauma and stress. It is led by trained peer mentors who are also living with HIV, allowing participants to learn from people who understand their experiences. The six-session program gives participants the option of meeting one-on-one with a peer mentor or participating in a small group, depending on what they find most comfortable. The program will be tested in partnership with Jamaica AIDS Support for Life (JASL), one of Jamaica's leading HIV service organizations. Sixty participants from JASL clinics in Kingston and St. Andrew, St. James, and St. Ann will take part in the intervention. Participants will be randomly assigned to either receive the Gwan Enjoy Life program or continue with their usual care, and they will be followed for one year. Researchers will examine whether the program improves mental health, strengthens social support, helps participants stay engaged in HIV care, and improves medication adherence.\n\nThe goal of the intervention is to determine whether the Gwan Enjoy Life intervention is a practical and effective program that can be expanded to reach more people across Jamaica. The findings will help researchers, healthcare providers, and policymakers better understand how stigma, violence, and mental health affect HIV care and will support the development of programs that improve the health and well-being of sexual minority men living with HIV.",[404,26,525,526,527],"Pyschological Distress","Suicidal Ideation","Engagement in HIV Care",[404,26,529,530,531,532],"Engagement in Care","Jamaica","Sexual Minority Men","Psychological Distress",{"date":336,"type":35},{"date":535,"type":22},"2026-08-25",{"date":537,"type":22},"2027-08-30",{"name":539,"class":75},"University of California, San Francisco",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":237,"sex":189,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":53,"phases":549,"briefSummary":550,"conditions":551,"keywords":561,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":43},"100592937","enhanced-mentor-mother-strategy-for-pregnant-and-postpartum-women-living-with-hiv-100592937","NCT06999928","Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV","Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy","PIE-eMMs","Inclusion Criteria:\n\n* Pregnant and postpartum women living with HIV (and their infants born during the study)\n* ≥18 years of age\n* Enrolled in PMTCT services at BFSDH\n* Able to understand and provide informed consent in English or Kiswahili\n\nExclusion Criteria:\n\n* Women who are not pregnant or postpartum\n* \\\u003C18 years of age\n* Not enrolled in PMTCT services at BFSDH\n* Unable to understand and provide informed consent in English or Kiswahili\n* Cognitive impairment that would interfere with ability to participate in the study",{"count":85,"type":22},[55],"Mentor Mothers (MMs) are peer supporters who help pregnant and postpartum women living with HIV (WLHIV) as they receive prevention of mother-to-child transmission of HIV (PMTCT) services in resource-limited settings like Kenya. Differentiated service delivery (DSD) is a care model that tailors services based on clients' needs, helping to improve both the quality and efficiency of care.\n\nThis hybrid implementation-effectiveness study will test whether an enhanced MM strategy that uses DSD can be successfully carried out and improve health outcomes for mothers and infants. The study will take place at Burnt Forest Sub-District Hospital (BFSDH) in Kenya.\n\nResearchers will ask:\n\n* Can the enhanced MM strategy be delivered as planned and accepted by patients and staff?\n* Does the strategy improve clinical outcomes like keeping mothers in PMTCT care, achieving HIV viral suppression, completing infant HIV testing, and preventing HIV transmission to infants? Researchers will compare health outcomes before and after the strategy is introduced at BFSDH, and also compare outcomes at other similar clinics that continue with standard MM services.\n\nWomen who choose to participate will meet with a MM during their routine antenatal and postnatal clinic visits. They will be offered the enhanced MM support, but can choose to receive standard care if they prefer.",[132,552,553,554,555,556,557,558,559,560],"Transmission Vertical","Viremia","Adherence, Treatment","Stigmatization","Socioeconomic Adversity","Health Care Utilization","Health Care Acceptability","Peer Group","Mothers",[562,563,564,565,566,567,478],"prevention of mother-to-child transmission","retention","implementation","mentor mothers","differentiated service delivery","maternal-child health",{"date":412,"type":35},{"date":570,"type":35},"2025-07-10",{"date":572,"type":22},"2026-10-12",{"name":74,"class":75},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":156,"minAge":581,"maxAge":582,"enrollmentInfo":583,"targetDuration":4,"studyType":53,"phases":585,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":43},"100530732","combination-intervention-to-enhance-treatment-engagement-and-viral-suppression-among-sexual-and-gender-minority-youth-in-nigeria-100530732","NCT06190613","Combination Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria","Adapting and Testing a Combination Peer Navigation and mHealth Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria","Inclusion Criteria:\n\n* HIV seropositive\n* registered as a patient at one of the collaborating key population (KP)-focused community centers\n* male sex at birth\n* identify as YMSM or YTW (or report a history of sex with men)\n* understand and read basic English, Yoruba, or Pidgin English\n* intention to remain a patient at a collaborating clinic during the 24-week follow-up period\n* has a cellphone\n\nExclusion Criteria:\n\n* Unable to obtain parental permission if 15 years of age and not emancipated","15 Years","29 Years",{"count":584,"type":22},110,[55],"The study will adapt and test a combination peer navigation and mHealth approach, Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria), to improve HIV treatment engagement, medication adherence and viral suppression among YMSM and YTW, ages 15-29.",[26],"2026-08-06",{"date":504,"type":35},{"date":591,"type":35},"2024-11-28",{"date":593,"type":22},"2026-12-31",{"name":595,"class":75},"Northwestern University",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":498,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":53,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":43},"100513442","high-intensity-exercise-to-combat-vascular-and-cognitive-dysfunction-in-adults-with-hiv-100513442","NCT05965518","High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV","A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults With HIV","Inclusion Criteria:\n\n* Age 50 years and older\n* Sedentary lifestyle, defined as \\\u003C 150 min\u002Fwk moderate physical activity as assessed by CHAMPS questionnaire\n* Neurocognitive Impairment (as assessed using the BRACE+\n* Prescribed HIV ART for ≥ 12 months, with no current use of older drugs with established mitochondrial toxicity\n* Able to speak, read, and write in English\n* Willingness to participate in all study procedures\n\nExclusion Criteria:\n\n* Diagnosis of mitochondrial disease\n* Active substance abuse or factors preventing compliance or safety\n* Uncontrolled hypertension, defined as resting BP \\> 150\u002F90 mmHG\n* Chronic kidney disease\n* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina\n* Acute myocardial infarction identified by medical history and ECG\n* Pulmonary disease requiring the use of supplemental oxygen\n* Poorly controlled diabetes\n* Neuropsychologically Intact\n* Orthopedic problems that limit ability to perform exercise\n* Simultaneous participation in another intervention trial",{"count":521,"type":22},[55],"This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 16 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at each visit, with baseline data collected at the initial visit with a 3-month follow-up occurring following completion of the intervention.",[26,607,608],"Arterial Stiffness","Cognitive Dysfunction",{"date":412,"type":35},{"date":611,"type":35},"2024-02-05",{"date":613,"type":22},"2028-12",{"name":615,"class":75},"University of Alabama at Birmingham",{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":625,"conditions":626,"keywords":631,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":4,"leadSponsor":639,"locationsCount":43},"100058758","specimen-collections-from-participants-with-hiv-infection-kshv-infection-viral-related-pre-malignant-lesions-and-cancer-100058758","NCT00006518","Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer","Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and\u002For Cancer","* INCLUSION CRITERIA:\n* Age 18 years or older.\n* ECOG performance status less than or equal to 3\n\nAt least one of the following:\n\n* Exposure risk to HIV, KSHV, or HPV\n* HIV seropositive\n* KSHV seropositive\n* EBV seropositive\n* HTLV-1 seropositive\n\nNOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if participants have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma \\[PEL\\], or KSHV-multicentric Castleman s disease \\[MCD\\]), this is sufficient to meet this criterion for eligibility.\n\n* Malignancy, MCD, or skin lesions with appearance of KS\n* Cervical or anal intraepithelial lesion\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone",{"count":624,"type":22},1029,"BACKGROUND:\n\n* A number of important scientific advances can be made through the study of blood, bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with Kaposi s sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or cancer.\n* This protocol provides a mechanism to affect a variety of such studies.\n\nOBJECTIVES:\n\n-Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.\n\nELIGIBILITY:\n\n-Eligibility criteria include age 18 years or older and at least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; malignancy, Castleman s disease, or skin lesions with appearance of Kaposi s sarcoma; or cervical or anal intraepithelial lesion.\n\nDESIGN:\n\n* Up to 999 subjects will be enrolled in this study.\n* Blood samples may be collected at the initial visit, and at follow-up visits.\n* Other fluids\u002Fexcretions may be collected (such as urine, saliva, semen, and stool).\n* Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal risk to the participants.\n* Specific risks will be described in a separate consent to be obtained at the time of the biopsy.\n* Samples will be studied in the HIV and AIDS Malignancy Branch, CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.",[26,627,628,629,630],"Kaposi's Sarcoma","Lymphomas","Multicentric Castleman's Disease","Primary Effusion Lymphoma",[632,633,26,634,635,220],"Tumor","Viruses","KSHV","AIDS",{"date":504,"type":35},{"date":638,"type":35},"2000-12-06",{"name":301,"class":42},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":237,"sex":17,"minAge":18,"maxAge":214,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":648,"conditions":649,"keywords":650,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":4,"leadSponsor":658,"locationsCount":43},"100054370","viral-load-in-blood-and-lymph-tissues-in-people-living-with-hiv-100054370","NCT00001316","Viral Load in Blood and Lymph Tissues in People Living With HIV","A Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in People Living With HIV","* INCLUSION CRITERIA:\n\n  1. HIV status must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia.\n  2. Aged 18 years or older.\n  3. Ability to give informed, written consent.\n  4. The following laboratory values:\n\n     1. Absolute neutrophil count of greater than 1000\u002Fmm\\^3\n     2. PT, PTT, within normal limits, (unless PTT is elevated in presence of positive lupus anticoagulant in a participant with no prior history of abnormal bleeding).\n     3. Adequate blood counts (PLWH: hemoglobin \\>= 9.0 g\u002FdL, HCT \\>= 28%, platelets \\>= 75,000; participants without HIV: hemoglobin \\>=11.2 g\u002FdL, HCT \\>=34.1%, platelets \\>=150,000)\n     4. Blood pressure \\\u003C=180\u002F100; pulse rate 50-100, unless a lower pulse rate is considered normal for the participant\n  5. Participants who do not have HIV will qualify as control participants.\n  6. Participants must have a clinically palpable lymph node in an easily accessible location.\n  7. Willingness to allow blood samples to be used for future studies of HIV infection\u002Fpathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening\n\nEXCLUSION CRITERIA:\n\n1. Women who are pregnant and\u002For breast-feeding\n2. Currently abusing alcohol or other drugs including narcotics or cocaine\n3. Participants with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.\n4. No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.\n5. Any medical condition for which the PI feels LN BX might be contraindicated\n6. Participants in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.",{"count":193,"type":22},"This is a study to determine the effect of the human immunodeficiency virus (HIV) on lymphoid tissues (e.g., lymph nodes) as compared to peripheral white blood cells. We have shown in previous studies that the lymph node is a major site of accumulation of HIV in the body, as well as being a site where much of the viral replication occurs which leads to the destruction of the body's immune system. To better understand the role of the lymph node in HIV infection and destruction of one s immunity, we wish to examine both the virus itself as well as the effects it is having on various types of white cells (called lymphocytes) obtained simultaneously from both peripheral blood and lymph nodes of people living with HIV (PLWH). We also need to look at cells derived from blood and lymph nodes from people who do not have HIV to serve as a control for experiments. We may also use your lymph node tissue and blood cells to attempt to make new T-cells, or rebuild the immune cells, in the laboratory by adding various factors or other substances released by different cells in the body. If you are living with HIV, you may be asked to undergo a second biopsy six weeks to 12 months after the first biopsy. Because of the ability of aspirin to interfere with blood clotting, you must have refrained from the use of aspirin for one week (7 days) prior to the biopsy date. You also cannot use non-aspirin containing, non-steroidal, anti-inflammatory medications (e.g., ibuprofen, naproxen, and similar drugs) one week (7 days) prior to the biopsy. In addition, pregnancy testing will be performed on all females at the time of admission and a positive test will exclude you from participation. No participant will undergo more than six biopsies while participating in this study unless a particular research requires it.",[26],[651,652,653,635,654,220],"Lymph Node","Polymerase Chain Reaction (PCR)","In Situ Hybridization","Excisional Biopsy",{"date":504,"type":35},{"date":657,"type":35},"1992-08-26",{"name":230,"class":42}]