protocolSection identificationModule nctId: NCT06333808, orgStudyIdInfo id: GS-US-621-6290, secondaryIdInfos id: 2023-510022-33, type: OTHER, domain: European Medicines Agency, briefTitle: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy, acronym: ARTISTRY-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Gilead Sciences, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH., conditionsModule conditions: HIV-1-infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 546, type: ESTIMATED, armsInterventionsModule interventions name: Bictegravir, interventions name: Lenacapavir, interventions name: B/F/TAF, interventions name: Placebo to match B/F/TAF, interventions name: Placebo to match BIC/LEN, outcomesModule primaryOutcomes measure: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48, secondaryOutcomes measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96, secondaryOutcomes measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48, secondaryOutcomes measure: Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruane Medical and Clinical Research Institute, status: RECRUITING, city: Los Angeles, state: California, zip: 90036, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Therafirst Medical Center, status: RECRUITING, city: Fort Lauderdale, state: Florida, zip: 33308, country: United States, geoPoint lat: 26.12231, lon: -80.14338, locations facility: Midway Immunology and Research Center, status: RECRUITING, city: Fort Pierce, state: Florida, zip: 34982, country: United States, geoPoint lat: 27.44671, lon: -80.32561, locations facility: Infectious Disease Specialists of Atlanta, status: RECRUITING, city: Decatur, state: Georgia, zip: 30033, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Southhampton Community Healthcare, Inc., status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63139, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: South Jersey Infectious Disease, status: RECRUITING, city: Somers Point, state: New Jersey, zip: 08244, country: United States, geoPoint lat: 39.31762, lon: -74.5946, locations facility: The Crofoot research Center, INC., status: RECRUITING, city: Houston, state: Texas, zip: 77098, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False