Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection.
- Кому может быть актуально
- Состояния в реестре: HIV-1-infection. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Вмешательства
- Препарат GS-3242 Tablet
Administered orally - Препарат GS-3242 Injection
Administered intramuscularly (IM) - Препарат Lenacapavir Tablet
Administered orally - Препарат Lenacapavir Injection
Administered IM - Препарат B/F/TAF
Administered orally
Первичные конечные точки
- 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Week 52]
Вторичные конечные точки (12)
- 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 [Срок оценки: 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 [Срок оценки: Week 52]
- Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12 [Срок оценки: Baseline, Week 12]
- Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35 [Срок оценки: Baseline, Week 35]
- Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52 [Срок оценки: Baseline, Week 52]
- Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26 [Срок оценки: Baseline, Week 26]
- Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12 [Срок оценки: From first dose date up to Week 12]
- Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35 [Срок оценки: Week 35]
- Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Week 18]
- Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35 [Срок оценки: Week 35]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07708727 · GS-US-643-6557 · 2026-526026-40