A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
第2相
実施中（募集終了）
NCT05729568
| 対象疾患 | HIV-1 Infection |
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| 相 | 第2相 |
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| スポンサー | Gilead Sciences |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 83 名 |
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| 介入（薬剤） | Teropavimab, Zinlirvimab, Lenacapavir Tablet, Lenacapavir Injection, Antiretroviral Therapy |
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| 開始日 | 2023年5月15日 |
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| 完了日 | 2024年7月2日 |
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| 結果公開日 | 2025年7月15日 |
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概要
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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