A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV 1

Condition studied

HIV

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24, Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24, Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24, Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48, Phase 3: Percentage of Participants Who Experience an AE at Week 48, Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48

Endpoint detail

Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48, Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96, Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24, Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48, Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96, Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24, Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48, Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96, Phase 2: Percentage of Participants Who Experience an AE, Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE, Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24, Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48, Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96, Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96, Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48, Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96, Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 48, Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 96, Phase 3: Percentage of Participants Who Experience an AE, Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE, Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48, Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96, Phase 3: Mean Change From Baseline in Body Weight at Week 48, Phase 3: Mean Change From Baseline in Body Weight at Week 96