Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).
The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.
The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Gilead Clinical Study Information Center
- 电话号码：1-833-445-3230 (GILEAD-0)
- 邮箱：GileadClinicalTrials@gilead.com
学习地点
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Florida
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Ft. Pierce、Florida、美国、34982
- 招聘中
- Midway Immunology and Research Center
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Texas
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Houston、Texas、美国、77098
- 招聘中
- The Crofoot Research Center, INC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up.
- Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception.
- Negative serum pregnancy test at screening and negative urine test at enrollment.
- Receiving B/F/TAF for ≥ 6 months prior to screening.
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months before and at screening.
- No 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) on available historical resistance reports.
- CD4 ≥ 200 cells/mm^3 at screening
Key Exclusion Criteria:
- Plans to breastfeed during the study period and 60 days following the last dose of study intervention.
- History of virologic failure while on an integrase strand-transfer inhibitor-based regimen.
- Creatinine clearance according to the Cockcroft-Gault formula < 60 mL/min.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Treatment Arm A: B/F/TAF
Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
Tablet administered orally
其他名称：
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实验性的：Treatment Arm B: GS-3242 + LEN
Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment C), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
Tablet administered orally Tablet administered orally
其他名称：
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实验性的：Treatment Arm C: GS-3242 + LEN
Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment Arm B), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
Tablet administered orally Tablet administered orally
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm
大体时间：Week 24
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Week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm
大体时间：Week 12
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Week 12
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Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm
大体时间：Week 48
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Week 48
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Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
大体时间：Week 12
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Week 12
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Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
大体时间：Week 24
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Week 24
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Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
大体时间：Week 48
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Week 48
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Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
大体时间：Week 12
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Week 12
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Change From Baseline in CD4 Cell Count at Week 24
大体时间：Week 24
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Week 24
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Change From Baseline in CD4 Cell Count at Week 48
大体时间：Week 48
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Week 48
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12
大体时间：Week 12
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Week 12
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24
大体时间：Week 24
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Week 24
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48
大体时间：Week 48
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Week 48
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Pharmacokinetic (PK) Parameter: Cmax of GS-3242
大体时间：Up to 48 weeks
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Cmax is defined as the maximum observed concentration of drug. |
Up to 48 weeks
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PK Parameter: Tmax of GS-3242
大体时间：Up to 48 weeks
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Tmax is defined as the time (observed time point) of Cmax. |
Up to 48 weeks
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PK Parameter: Ctau of GS-3242
大体时间：Up to 48 weeks
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Ctau is defined as the observed drug concentration at the end of the dosing interval. |
Up to 48 weeks
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PK Parameter: AUCtau of GS-3242
大体时间：Up to 48 weeks
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Up to 48 weeks
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合作者和调查者
调查人员
- 研究主任：Gilead Study Director、Gilead Sciences
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- GS-US-782-8079-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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