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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 11
- 主要终点
- 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
研究概览
简要总结
The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.
The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.
The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.
The primary objectives of this study are:
Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.
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
- •HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening.
- •Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening.
排除标准
- •Prior usage of, or exposure to LEN or GS-3242
- •Prior use of any long-acting parenteral ARV 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
Phase 2: 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 for at least 52 weeks.
干预措施: GS-3242 Tablet (Drug)
Phase 2: Part A: Group 3 of B/F/TAF
Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks.
干预措施: B/F/TAF (Drug)
Phase 2: Part B: Group 4 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 injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.
干预措施: GS-3242 Tablet (Drug)
Phase 2: Part A: Group 2 of GS-3242 + LEN
Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks.
干预措施: GS-3242 Tablet (Drug)
Phase 2: Part A: Group 2 of GS-3242 + LEN
Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks.
干预措施: GS-3242 Injection (Drug)
Phase 3: Group 2 of B/F/TAF
Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks.
干预措施: B/F/TAF (Drug)
Phase 2: 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 for at least 52 weeks.
干预措施: Lenacapavir Tablet (Drug)
Phase 2: Part A: Group 2 of GS-3242 + LEN
Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks.
干预措施: Lenacapavir Tablet (Drug)
Phase 3: 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 IM injections of GS-3242 and LEN for at least 104 weeks.
干预措施: Lenacapavir Injection (Drug)
Phase 2: 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 for at least 52 weeks.
干预措施: Lenacapavir Injection (Drug)
Phase 2: 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 for at least 52 weeks.
干预措施: GS-3242 Injection (Drug)
Phase 2: Part B: Group 4 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 injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.
干预措施: GS-3242 Injection (Drug)
Phase 3: 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 IM injections of GS-3242 and LEN for at least 104 weeks.
干预措施: GS-3242 Tablet (Drug)
Phase 3: 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 IM injections of GS-3242 and LEN for at least 104 weeks.
干预措施: GS-3242 Injection (Drug)
Phase 2: Part A: Group 2 of GS-3242 + LEN
Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks.
干预措施: Lenacapavir Injection (Drug)
Phase 2: Part B: Group 4 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 injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.
干预措施: Lenacapavir Injection (Drug)
Phase 3: 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 IM injections of GS-3242 and LEN for at least 104 weeks.
干预措施: Lenacapavir Tablet (Drug)
Phase 2: Part B: Group 4 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 injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.
干预措施: Lenacapavir Tablet (Drug)
结局指标
主要结局
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
时间窗: Week 35
Phase 2: 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
Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
时间窗: Week 52
次要结局
- Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104(From first dose up to Week 104)
- Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm(Week 12)
- Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm(Week 52)
- Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12(Baseline, Week 12)
- Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35(Baseline, Week 35)
- Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52(Baseline, Week 52)
- Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26(Baseline, Week 26)
- Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12(From first dose date up to Week 12)
- Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35(Week 35)
- Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26(From first dose date up to Week 26)
- Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52(From first dose date up to Week 52)
- Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18(Week 18)
- Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35(Week 35)
- Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52(Week 52)
- Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26(Week 26)
- Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm(Week 104)
- Phase 3: Change From Baseline in CD4 Cell Count at Week 52(Baseline, Week 52)
- Phase 3: Change From Baseline in CD4 Cell Count at Week 104(Baseline, Week 104)
- Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52(From first dose up to Week 52)