An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination with Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

Condition studied

human immunodeficiency virus type 1 (HIV-1)

Investigational medicinal product(s)

Every trial of GS-3242, B/F/TAF and Lenacapavir across our registers →

Eligibility

Primary endpoint

Phase 2: Part A: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 35 as determined by the United States (US) Food and Drug Administration (FDA) snapshot algorithm, Phase 2: Part B: The proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26 as determined by the US FDA snapshot algorithm, Phase 3: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 52 as determined by the FDA snapshot algorithm

Endpoint detail

Phase 2: Part A: Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12 and 52 as determined by the US FDA snapshot algorithm, Phase 2: Part A: Change from baseline in CD4 cell count at Weeks 12, 35, and 52, Phase 2: Part A: Proportion of participants experiencing treatment-emergent adverse events (AEs) through Weeks 12, 35, and 52, Phase 2: Part B: Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12 and 52 as determined by the US FDA snapshot algorithm, Phase 2: Part B: Change from baseline in CD4 cell count at Weeks 12, 26, and 52, Phase 2: Part B: Proportion of participants experiencing treatment-emergent AEs through Weeks 12, 26 and 52, Phase 2: Trough concentrations in Treatment Groups 1 and 2 at Weeks 18, 35, and 52 of Part A and in Treatment Group 4 at Weeks 26 and 52 of Part B for GS-3242 and LEN, Phase 3: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm, Phase 3: Change from baseline in CD4 cell count at Weeks 52 and 104, Phase 3: The proportion of participants experiencing treatment-emergent AEs, and treatment-emergent laboratory abnormalities through Weeks 52 and 104