A Phase 2 Randomized, 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 Virologically Suppressed People With HIV-1
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 55
- 主要终点
- 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
研究概览
简要总结
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.
The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL for ≥ 6 months before screening.
- •Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- •Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.
- •No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S).
排除标准
- •Prior use of, or exposure to GS-3242 or LEN.
- •History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.
- •Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part B: Group 4 (Conditional) of GS-3242 + LEN
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
干预措施: GS-3242 Injection (Drug)
Part A: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.
干预措施: GS-3242 Tablet (Drug)
Part A: Group 2 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
干预措施: GS-3242 Injection (Drug)
Part B: Group 4 (Conditional) of GS-3242 + LEN
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
干预措施: GS-3242 Tablet (Drug)
Part A: Group 2 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
干预措施: Lenacapavir Tablet (Drug)
Part A: Group 2 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
干预措施: GS-3242 Tablet (Drug)
Part B: Group 4 (Conditional) of GS-3242 + LEN
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
干预措施: Lenacapavir Injection (Drug)
Part B: Group 4 (Conditional) of GS-3242 + LEN
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
干预措施: Lenacapavir Tablet (Drug)
Part A: Group 3 of B/F/TAF
Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks.
干预措施: B/F/TAF (Drug)
Part A: Group 2 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
干预措施: Lenacapavir Injection (Drug)
Part A: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.
干预措施: GS-3242 Injection (Drug)
Part A: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.
干预措施: Lenacapavir Injection (Drug)
Part A: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.
干预措施: Lenacapavir Tablet (Drug)
结局指标
主要结局
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
时间窗: Week 35
Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
时间窗: Week 26
次要结局
- Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm(Week 26)
- Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26(Up to Week 26)
- Part A and Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm(Week 52)
- Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the US FDA Snapshot Algorithm(Week 35)
- Part A and Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm(Week 52)
- Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35(Baseline, Week 35)
- Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52(Baseline, Week 52)
- Part B: Change From Baseline in CD4 Cell Count at Week 26(Baseline, Week 26)
- Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35(Up to Week 35)
- Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52(Up to Week 52)
- Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18(Week 18)
- Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35(Week 35)
- Part A: Group 1 and 2 and Part B: Groups 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 52(Week 52)
- Part B: Trough Concentrations at GS-3242 and LEN at Week 26(Week 26)