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)
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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