[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471449":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":53,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ATI","EXPERIMENTAL","Participants randomized to ATI will halt their ART medications starting 2 weeks (more or less 3 days) after the first imaging visit. This plan will be discussed with participants during the baseline visit. Patients will be contacted 1-3 days prior to ATI initiation. ATI may be delayed or cancelled if there are new safety concerns. HIV plasma viral levels and CD4 counts will be monitored every week during the ATI phase. If a participant meets any of the ART restart criteria during the ATI phase, then they will discontinue ATI and restart ART. Participants who do not meet restart criteria will remain off ART and continue to be monitored weekly until they have been on ATI for 90 days, and then will restart ART.",[13],"Other: Acute Treatment Interruption",{"label":15,"type":16,"description":17,"interventionNames":18},"Continue ART","NO_INTERVENTION","Participants will continue on their pre-study ART throughout the trial.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"OTHER","Acute Treatment Interruption",[9],[25],{"name":26,"affiliation":27,"role":28},"Chuen-Yen C Lau, M.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","(240) 858-7088","lauc@mail.nih.gov",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-77.10026,38.98067,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":18,"email":18},"For more information at the NIH Clinical Center contact National Cancer Institute Referral Office","888-624-1937",{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100471449","phase-2-imaging-and-biopsy-of-people-with-hiv-1-undergoing-analytic-treatment-interruption-100471449",false,"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.","ALL","18 Years","100 Years",{"count":65,"type":66},50,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","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.",[72],"HIV",[74,75,76,77],"Human Immunodeficiency Virus","Antiretroviral Therapy","FDG-PET","Reservoir","2026-08-12",{"date":80,"type":81},"2026-08-13","ACTUAL",{"date":83,"type":81},"2023-01-09",{"date":85,"type":66},"2029-08-01",{"name":27,"class":6},1]