A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Фаза 2
Идёт, набор закрыт
NCT05729568
| Заболевание | HIV-1 Infection |
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| Фаза | Фаза 2 |
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| Спонсор | Gilead Sciences |
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| Статус | Идёт, набор закрыт |
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| Участники | 83 участн. |
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| Вмешательство | Teropavimab, Zinlirvimab, Lenacapavir Tablet, Lenacapavir Injection, Antiretroviral Therapy |
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| Дата начала | 15.05.2023 |
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| Дата завершения | 2.07.2024 |
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| Публикация результатов | 15.07.2025 |
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Кратко
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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