[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657769":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":11,"studyPopulation":11,"armGroups":57,"interventions":75,"overallOfficials":91,"centralContacts":95,"locations":11,"responsibleParty":101,"collaborators":11,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":11,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":11,"enrollmentInfo":112,"targetDuration":11,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":11,"overallStatus":121,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":11},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies\u002FmL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm",null,"Week 24",[14,17,20,22,24,26,28,30,32,34,36,38,42,45,48],{"measure":15,"description":11,"timeFrame":16},"Proportion of Participants With HIV-1 RNA ≥ 50 copies\u002FmL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm","Week 12",{"measure":18,"description":11,"timeFrame":19},"Proportion of Participants With HIV-1 RNA ≥ 50 copies\u002FmL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm","Week 48",{"measure":21,"description":11,"timeFrame":16},"Proportion of Participants With HIV-1 RNA \u003C 50 Copies\u002FmL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm",{"measure":23,"description":11,"timeFrame":12},"Proportion of Participants With HIV-1 RNA \u003C 50 Copies\u002FmL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm",{"measure":25,"description":11,"timeFrame":19},"Proportion of Participants With HIV-1 RNA \u003C 50 Copies\u002FmL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm",{"measure":27,"description":11,"timeFrame":16},"Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12",{"measure":29,"description":11,"timeFrame":12},"Change From Baseline in CD4 Cell Count at Week 24",{"measure":31,"description":11,"timeFrame":19},"Change From Baseline in CD4 Cell Count at Week 48",{"measure":33,"description":11,"timeFrame":16},"The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12",{"measure":35,"description":11,"timeFrame":12},"The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24",{"measure":37,"description":11,"timeFrame":19},"The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48",{"measure":39,"description":40,"timeFrame":41},"Pharmacokinetic (PK) Parameter: Cmax of GS-3242","Cmax is defined as the maximum observed concentration of drug.","Up to 48 weeks",{"measure":43,"description":44,"timeFrame":41},"PK Parameter: Tmax of GS-3242","Tmax is defined as the time (observed time point) of Cmax.",{"measure":46,"description":47,"timeFrame":41},"PK Parameter: Ctau of GS-3242","Ctau is defined as the observed drug concentration at the end of the dosing interval.",{"measure":49,"description":50,"timeFrame":41},"PK Parameter: AUCtau of GS-3242","AUCtau is defined as the area under the concentration versus time curve over the dosing interval.",{"allocation":52,"interventionModel":53,"interventionModelDescription":11,"primaryPurpose":54,"observationalModel":11,"timePerspective":11,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":11,"whoMasked":11},"NONE",[58,64,71],{"label":59,"type":60,"description":61,"interventionNames":62},"Treatment Arm A: B\u002FF\u002FTAF","ACTIVE_COMPARATOR","Participants will receive B\u002FF\u002FTAF 50\u002F200\u002F25 mg once daily for at least 48 weeks.\n\nAfter Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.",[63],"Drug: B\u002FF\u002FTAF",{"label":65,"type":66,"description":67,"interventionNames":68},"Treatment Arm B: GS-3242 + LEN","EXPERIMENTAL","Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment C), administered concomitantly for at least 48 weeks.\n\nAfter Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.",[69,70],"Drug: GS-3242","Drug: Lenacapavir",{"label":72,"type":66,"description":73,"interventionNames":74},"Treatment Arm C: GS-3242 + LEN","Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment Arm B), administered concomitantly for at least 48 weeks.\n\nAfter Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.",[69,70],[76,83,86],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"DRUG","B\u002FF\u002FTAF","Tablet administered orally",[59],[82],"Biktarvy®",{"type":77,"name":84,"description":79,"armGroupLabels":85,"otherNames":11},"GS-3242",[65,72],{"type":77,"name":87,"description":79,"armGroupLabels":88,"otherNames":89},"Lenacapavir",[65,72],[90],"LEN",[92],{"name":93,"affiliation":5,"role":94},"Gilead Study Director","STUDY_DIRECTOR",[96],{"name":97,"role":98,"phone":99,"phoneExt":11,"email":100},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",{"type":102,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657769","phase-2-substudy-01-a-study-of-long-acting-hiv-1-treatments-taken-by-mouth-in-people-with-hiv-1-with-undetectable-virus-levels-100657769",false,"NCT07841990","Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels","A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1","Key Inclusion Criteria:\n\n* Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up.\n* Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception.\n* Negative serum pregnancy test at screening and negative urine test at enrollment.\n* Receiving B\u002FF\u002FTAF for ≥ 6 months prior to screening.\n* Documented plasma HIV-1 RNA \\\u003C 50 copies\u002FmL for ≥ 6 months before and at screening.\n* No resistance to GS-3242 (integrase mutation Q148H\u002FK\u002FR plus at least 2 of the following integrase mutations: L74I\u002FM, T97A, E138A\u002FK\u002FT, or G140A\u002FC\u002FS) on available historical resistance reports.\n* CD4 ≥ 200 cells\u002Fmm\\^3 at screening\n\nKey Exclusion Criteria:\n\n* Plans to breastfeed during the study period and 60 days following the last dose of study intervention.\n* History of virologic failure while on an integrase strand-transfer inhibitor-based regimen.\n* Creatinine clearance according to the Cockcroft-Gault formula \\\u003C 60 mL\u002Fmin.","ALL","18 Years",{"count":113,"type":114},125,"ESTIMATED","INTERVENTIONAL",[117],"PHASE2","Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).\n\nThe main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B\u002FF\u002FTAF for at least 6 months prior to study start.\n\nThe primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B\u002FF\u002FTAF in virologically suppressed PWH at Week 24.",[120],"HIV-1 Infection","NOT_YET_RECRUITING","2026-09-21",{"date":124,"type":125},"2026-09-25","ACTUAL",{"date":127,"type":114},"2026-09",{"date":129,"type":114},"2033-07",{"name":5,"class":6}]