A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
2期
进行中（已停止招募）
NCT05729568
| 适应症 | HIV-1 Infection |
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| 分期 | 2期 |
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| 申办方 | Gilead Sciences |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 83 人 |
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| 干预（药物） | Teropavimab, Zinlirvimab, Lenacapavir Tablet, Lenacapavir Injection, Antiretroviral Therapy |
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| 开始日期 | 2023年5月15日 |
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| 完成日期 | 2024年7月2日 |
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| 结果公布日 | 2025年7月15日 |
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摘要
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Week 26 · percentage of participants
| Randomized Phase Treatment Group 1: LEN + TAB+ ZAB | 1.9 percentage of participants |
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| Randomized Phase Treatment Group 3: SBR | 0.0 percentage of participants |
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| p-value | 1.0000 |
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| Difference in Percentages | 1.9 (95% CI -11.2–10.6) |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。