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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 24 centers

• 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
• … and 16 more centers

France · 7 centers

• 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

Argentina · 6 centers

• 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

Spain · 6 centers

• 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

Chile · 3 centers

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

Guatemala · 3 centers

• 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

South Africa · 3 centers

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

Canada · 2 centers

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

Mexico · 1 center

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗