[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infection-human-immunodeficiency-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infection-human-immunodeficiency-virus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100647728","phase-1-efficacy-and-safety-of-acc017-tablets-compared-with-dolutegravir-sodium-tablets-in-treatment-nave-adults-with-human-immunodeficiency-virus-type-1-hiv-1-100647728",false,"NCT07711223","Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)","A Multicenter, Randomized, Double-Blind, Double-Dummy, Dolutegravir Sodium Tablets Controlled, Phase III Study to Evaluate the Efficacy and Safety of ACC017 Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)","Inclusion Criteria:\n\nA participant will be excluded from the trial if they meet any one or more of the following criteria:\n\n1. Voluntarily sign the written informed consent form, demonstrate the ability to understand and comply with the requirements of the study protocol;\n2. Age ≥18 years (inclusive) at the time of providing informed consent, both male and female participants are eligible;\n3. Diagnosed with HIV infection prior to informed consent, and have an HIV RNA viral load ≥500 copies\u002FmL (tested at the local center) at screening;\n4. Have not received any ART since initial HIV diagnosis, and agree not to initiate any ART from the time of informed consent until randomization.\n\nExclusion Criteria:\n\n1. Participants judged by the investigator as having poor treatment compliance or protocol adherence, or any other condition making them unsuitable for the study, or when participation may not best protect the participant's health interests;\n2. At screening, female participants who are pregnant, breastfeeding, or have a positive blood pregnancy test; or from 1 month before screening until 3 months after the last dose of the investigational product, participants of childbearing potential (WOCBP) or male participants with plans for procreation (including egg or sperm donation), or unwilling to use effective contraception (including one or more non-pharmacological methods, or absence of heterosexual activity in daily life) or safety measures;\n3. At screening, judged by the investigator to be in the acute phase of HIV-1 infection, or with opportunistic infections or other clinically significant AIDS-defining conditions within 3 months before screening;\n4. At screening, judged by the investigator to have poorly controlled clinically significant diseases (including cardiovascular, respiratory, digestive, endocrine-metabolic, neuropsychiatric, hematological, and immune systems, etc.), including but not limited to: poorly controlled hypertension despite active treatment (resting SBP ≥160 mmHg or DBP ≥100 mmHg upon retest), NYHA Class III or IV cardiac function, GOLD Grade 3-4 COPD, severe liver impairment (Child-Pugh Class C), etc.;\n5. At screening, judged by the investigator to have clinically significant laboratory abnormalities, including but not limited to: hemoglobin (Hb) \\\u003C90 g\u002FL, or ALT \\>5 × ULN, or ALT \\>3 × ULN with total bilirubin (TBIL) \\>1.5 × ULN, or creatinine clearance \\\u003C30 mL\u002Fmin (CKD-EPI equation);\n6. At screening, HBsAg-positive with HBV DNA ≥2000 IU\u002FmL (local center testing), HCV antibody-positive with HCV RNA \\> LLOQ (local center testing), or judged by the investigator to require anti-syphilis treatment (participants who have completed standardized anti-syphilis treatment for ≥7 days may be considered);\n7. Use of pre-exposure prophylaxis (PrEP) and\u002For post-exposure prophylaxis (PEP) within 1 month before screening, or prior use of long-acting PrEP drugs (e.g., cabotegravir or lenacapavir, etc.);\n8. Within 30 days before screening, at screening, or planned use during the trial, systemic immunomodulators, cytotoxic drugs, etc. (see Appendix 7), and unwilling or unable to discontinue use from the time of informed consent;\n9. At screening, known history of allergy to the investigational product, structurally related drugs, or excipients; or history of allergic diseases requiring medication control before screening (e.g., asthma, urticaria, atopic dermatitis \\[eczema\\], etc.);\n10. Before screening, major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy); or at screening, judged by the investigator as likely to require elective major surgery during the trial;\n11. Within 5 years before screening, history of malignancy (except carcinoma in situ of the cervix treated by conization, or surgically cured basal cell carcinoma, squamous cell carcinoma, and\u002For carcinoma in situ \\[Bowen's disease\\] of the skin);\n12. Within 5 years before screening, history of alcohol, drug, or other substance abuse (non-medical excessive, inappropriate, or addictive use of alcohol, drugs, or other substances leading to social, psychological, or physiological impairment);\n13. Before or at screening, intolerance to venipuncture, history of needle or blood phobia, or blood donation (including component blood) or significant blood loss (≥400 mL) or transfusion within 3 months before screening, or plans to donate blood during the trial;\n14. Participation in any interventional clinical trial (including drugs, vaccines, or devices) within 3 months before screening.","ALL","18 Years",{"count":19,"type":20},660,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study employs a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group, non-inferiority design. The trial will be conducted in treatment-naïve adult patients with HIV-1, using Dolutegravir Sodium Tablets as the control, to demonstrate the efficacy and safety of the core investigational drug ACC017 combined with FTC\u002FTAF Tablets (II) compared to Dolutegravir Sodium combined with FTC\u002FTAF Tablets (II) in treating treatment-naïve adult HIV-1 patients.\n\nAfter initial screening eligibility is confirmed, participants will return to the clinic on Day 1 (D1) for re-evaluation of eligibility and completion of required examinations. Eligible participants will be randomized in a 1:1 ratio to receive either ACC017 Tablets (40 mg, once daily \\[QD\\]) or Dolutegravir Sodium Tablets (50 mg, QD). Both treatment groups will also receive FTC\u002FTAF Tablets (II) and will undergo 48 weeks of continuous double-blind treatment. Subsequently, all study participants will transition to open-label treatment with ACC017 combined with FTC\u002FTAF Tablets (III) for an additional 48 weeks (during which the dummy medication will no longer be administered).",[27],"Infection, Human Immunodeficiency Virus","RECRUITING","2026-07-13",{"date":31,"type":32},"2026-07-17","ACTUAL",{"date":34,"type":32},"2025-11-07",{"date":36,"type":20},"2028-12-31",{"name":38,"class":39},"Jiangsu Aidea Pharmaceutical Group Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":47,"phases":4,"briefSummary":48,"conditions":49,"keywords":50,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":59,"locationsCount":4},"100321280","gsk1265744-cabotegravir-cab-for-named-patientcompassionate-use-in-hiv-100321280","NCT03462810","GSK1265744 (Cabotegravir, CAB) for Named Patient\u002FCompassionate Use in HIV","Inclusion Criteria:\n\n* HIV-infected patients will be eligible for treatment if ALL the following apply:\n\n  * Male or female patients aged ≥ 18 yrs\n\nNOTE: all female patients of reproductive potential should use every precaution to prevent pregnancy including either complete abstinence from intercourse from 2 weeks prior to administration of CAB, throughout receipt of CAB and for at least 52 weeks after discontinuation of CAB LA; or use of one of the following methods of highly reliable contraception:\n\n1. Contraceptive subdermal implant\n2. Intrauterine device or intrauterine system\n3. Combined estrogen and progestogen oral contraceptive\n4. Injectable progestogen\n5. Contraceptive vaginal ring\n6. Percutaneous contraceptive patches\n7. Male partner sterilisation with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's: review of subject's medical records, medical examination and\u002For semen analysis, or medical history interview provided by her or her partner.\n\nThese allowed methods of contraception are only effective when used consistently\u002Fcorrectly and in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.\n\n* Inability to construct a viable antiviral treatment regimen with commercially available medications;\n* Demonstrated need for a long acting, injectable antiretroviral including, but not limited to malabsorption or inability to achieve adequate drug levels via oral route. NOTE: Poor\u002Fincomplete adherence to oral meds is not a sufficient rationale for inclusion.\n* The patient\u002Flegal guardian or representative has given informed consent to treatment prior to administering CAB (in a manner consistent with all national requirements). The patient\u002Flegal guardian or representative has also given informed consent for the transmission of a copy of the anonymized adverse and serious adverse event (SAE) and pregnancy reports (in compliance with local regulatory authority requirements) to GSK and ViiV where allowable by local regulations, and to the country regulatory authority as required.\n\nExclusion Criteria:\n\n* Patients will not be eligible for treatment if ANY of the following apply:\n\n  * Patient has estimated creatinine clearance \\\u003C50 mL\u002Fmin via Cockcroft-Gault method;\n  * Females who are pregnant or women who are breastfeeding, or plan to become pregnant or breastfeed during treatment.\n  * Patients who have had known or suspected allergic reaction or hypersensitivity reactions to integrase inhibitors;\n  * Alanine aminotransferase (ALT) \\>5 times the upper limit of normal (ULN)\n  * ALT ≥ 3 times ULN and bilirubin ≥ 1.5 times ULN (with \\> 35% direct bilirubin)\n  * Evidence for moderate to severe hepatic impairment, grade 3-4 liver fibrosis, or cirrhosis\n  * Patients who are eligible for actively enrolling clinical trials involving CAB.\n  * Significant coagulopathy precluding chronic IM dosing\n\nNOTE: Patients should not be treated via the named patient\u002Fcompassionate use program if they are eligible and\u002For able to participate in any of the Phase III clinical trials of CAB and the patient is suitable for participation in such clinical trials. In that instance (assuming consent is obtained) the patient should preferentially be enrolled into the ongoing clinical trial to allow detailed data collection. In accordance with national requirements patients should not be treated in the named patient\u002Fcompassionate use program if they have responded to previous treatment with CAB in another clinical trial without review and prior approval by the VSLC.","EXPANDED_ACCESS","The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and\u002For limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via https:\u002F\u002Fus.viivhealthcare.com\u002Fmedia\u002F124424\u002Fviivs-external-policy-on-cup\\_final-version\\_23feb2017.pdf.",[27],[51,52,53,54],"cabotegravir, CAB","GSK1265744","Individual Patient Compassionate Use","HIV","AVAILABLE","2021-05-19",{"date":58,"type":32},"2021-05-21",{"name":60,"class":39},"ViiV Healthcare"]