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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Treatments: Drug: ISL/ULO; Drug: ULO; Drug: BIC/FTC/TAF; Drug: ISL; Drug: Placebo to ISL/ULO; Drug: Placebo for BIC/FTC/TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT07266831

MK-8591B-062 (Other Identifier)

U1111-1323-4689 (Registry Identifier)

2025-522519-40 (Registry Identifier)

8591B-062

Details and patient eligibility

About

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.

Enrollment: 570 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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570 participants in 4 patient groups

Phase 2: ISL + ULO

Experimental group

Description:

Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks

Treatment:

Drug: ISL

Drug: ULO

Phase 2: BIC/FTC/TAF

Active Comparator group

Description:

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks

Treatment:

Drug: BIC/FTC/TAF

Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF

Experimental group

Description:

ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks

Treatment:

Drug: Placebo for BIC/FTC/TAF

Drug: ISL/ULO

Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO

Active Comparator group

Description:

BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks

Treatment:

Drug: Placebo to ISL/ULO

Drug: BIC/FTC/TAF