Status:

RECRUITING

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

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 ...

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.

Key Trial Info

Start Date :

December 18 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 3 2030

Estimated Enrollment :

570 Patients enrolled

Trial Details

Trial ID

NCT07266831

Start Date

December 18 2025

End Date

April 3 2030

Last Update

April 13 2026

Active Locations (34)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (34 locations)

1

Vivent Health ( Site 1519)

Denver, Colorado, United States, 80246

2

Whitman-Walker Institute ( Site 1538)

Washington D.C., District of Columbia, United States, 20032

3

Midway Immunology and Research Center ( Site 1503)

Ft. Pierce, Florida, United States, 34982

4

CAN Community Health- Miami Gardens ( Site 1549)

Miami Gardens, Florida, United States, 33055

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