Status:
ACTIVE_NOT_RECRUITING
A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared t...
Eligibility Criteria
Inclusion
- Inclusion:
- The main inclusion criteria include but are not limited to the following:
- \- Has been receiving Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression \[Human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \<50 copies/mL\] for ≥6 months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen.
- Exclusion:
- The main exclusion criteria include but are not limited to the following:
- 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) coinfection.
- Has hepatitis B virus (HBV) coinfection.
- 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.
Exclusion
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2031
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06891066
Start Date
April 14 2025
End Date
September 30 2031
Last Update
October 16 2025
Active Locations (23)
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1
Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)
San Francisco, California, United States, 94110
2
Mills Clinical Research ( Site 4109)
West Hollywood, California, United States, 90046
3
Georgetown University Medical Center ( Site 4106)
Washington D.C., District of Columbia, United States, 20007
4
Orlando Immunology Center ( Site 4103)
Orlando, Florida, United States, 32803