A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

Официальное название

A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1

Обзор

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Вмешательства

• Препарат ISL
  ISL 2 x 1 mg oral capsules administered qw for 96 weeks
• Препарат ULO
  ULO 2 x 100 mg oral tablets administered qw for 96 weeks
• Препарат BIC/FTC/TAF
  BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
• Препарат Placebo for BIC/FTC/TAF
  BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
• Препарат Placebo to ISL/ULO
  ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
• Препарат ISL/ULO
  ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

Первичные конечные точки

• Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 [Срок оценки: Week 24]
• Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24 [Срок оценки: Week 24]
• Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24 [Срок оценки: Week 24]
• Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 [Срок оценки: Week 48]
• Phase 3: Percentage of Participants Who Experience an AE at Week 48 [Срок оценки: Week 48]
• Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48 [Срок оценки: Week 48]

Вторичные конечные точки (12)

• Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 [Срок оценки: Week 48]
• Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 [Срок оценки: Week 96]
• Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24 [Срок оценки: Week 24]
• Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 [Срок оценки: Week 48]
• Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96 [Срок оценки: Week 96]
• Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24 [Срок оценки: Baseline (Day 1) and Week 24]
• Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48 [Срок оценки: Baseline (Day 1) and Week 48]
• Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96 [Срок оценки: Baseline (Day 1) and Week 96]
• Phase 2: Percentage of Participants Who Experience an AE [Срок оценки: Up to approximately 102 weeks]
• Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 96 weeks]
• Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24 [Срок оценки: Week 24]
• Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48 [Срок оценки: Week 48]

Критерии участия

Критерии включения

• Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
• Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
• Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\^3.
• Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.

Критерии исключения

• Has human immunodeficiency virus type 2 (HIV-2) infection.
• Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
• Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
• Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
• Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 24 центра

• Ruane Clinical Research Group, Inc. ( Site 1513) — Los Angeles
• Vivent Health ( Site 1519) — Denver
• Whitman-Walker Institute ( Site 1538) — Washington D.C.
• Midway Immunology and Research Center ( Site 1503) — Ft. Pierce
• CAN Community Health- Miami Gardens ( Site 1549) — Miami Gardens
• Orlando Immunology Center ( Site 1501) — Orlando
• CAN Community Health ( Site 1510) — Sarasota
• Triple O Research Institute ( Site 1505) — West Palm Beach
• … и ещё 16 центров

Франция · 7 центров

• Bordeaux University Hospital - Pellegrin ( Site 3605) — Bordeaux
• Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608) — Toulouse
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( — Nantes
• HOPITAL DE LA CROIX ROUSSE ( Site 3613) — Lyon
• Hôpital Avicenne ( Site 3602) — Bobigny
• Hôpital Saint-Louis ( Site 3600) — Paris
• Hôpital Bichat - Claude-Bernard ( Site 3601) — Paris

Аргентина · 6 центров

• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102) — Caba
• Fundación Huesped ( Site 3100) — CABA
• Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103) — Mar del Plata
• Fundación IDEAA ( Site 3101) — Buenos Aires
• Instituto CAICI SRL ( Site 3106) — Rosario
• Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105) — San Miguel de Tucumán

Испания · 6 центров

• Hospital Universitario La Paz ( Site 3404) — Madrid
• Consorcio Hospital General Universitario de Valencia ( Site 3406) — Valencia
• Hospital Universitari Vall d'Hebron ( Site 3402) — Barcelona
• HOSPITAL CLÍNIC DE BARCELONA ( Site 3400) — Barcelona
• Hospital Universitario 12 de Octubre ( Site 3405) — Madrid
• Complejo Hospitalario Virgen De La Victoria ( Site 3409) — Málaga

Чили · 3 центра

• Biomedica Research Group ( Site 4201) — Santiago
• Clínica Universidad de Los Andes ( Site 4207) — Santiago
• Espacio Eme ( Site 4202) — Santiago

Guatemala · 3 центра

• Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( S — Guatemala City
• MEDI-K ( Site 3803) — Guatemala City
• CELAN,S.A ( Site 3802) — Guatemala City

ЮАР · 3 центра

• Josha Research ( Site 4302) — Bloemfontein
• Wentworth Hospital ( Site 4303) — Durban
• Be Part Yoluntu Centre ( Site 4300) — Mbekweni, Paarl

Канада · 2 центра

• Spectrum Health ( Site 3307) — Vancouver
• Gestion clinique médicale l'Actuel ( Site 3303) — Montreal

Мексика · 1 центр

• Morales Vargas Centro de Investigacion, S.C. ( Site 4502) — León

Идентификаторы

NCT: NCT07266831 · 8591B-062 · U1111-1323-4689 · 2025-522519-40 · MK-8591B-062

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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