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NCT06891066 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06891066: Active Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, sponsored by Merck Sharp & Dohme.
NCT06891066 is a Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06891066, a Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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 to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.
Primary Outcome
Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA ≥50 copies/mL will be reported at week 24.
Conditions Studied
Interventions
- DRUG ISL
- DRUG ULO
- DRUG BIC/FTC/TAF
Study Locations (20)
Texas
- Central Texas Clinical Research ( Site 4100) - Austin
- Prism Health North Texas, Oak Cliff Health Center ( Site 4114) - Dallas
- DCOL Center for Clinical Research ( Site 4112) - Longview
Other
- Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301) - Ponce
- Clinical Research Puerto Rico ( Site 4300) - San Juan
- HOPE Clinical Research ( Site 4303) - San Juan
California
- Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107) - San Francisco
- Mills Clinical Research ( Site 4109) - West Hollywood
Florida
- Orlando Immunology Center ( Site 4103) - Orlando
- Triple O Research Institute ( Site 4111) - West Palm Beach
New South Wales
- Momentum Clinical Research - Darlinghurst ( Site 4260) - Darlinghurst
- St. Vincent's Hospital ( Site 4263) - Darlinghurst
Victoria
- The Alfred Hospital ( Site 4264) - Melbourne
- Prahran Market Clinic ( Site 4262) - Prahran
District of Columbia
- Georgetown University Medical Center ( Site 4106) - Washington D.C.
Georgia
- Chatham County Health Department - Chatham CARE Center ( Site 4116) - Savannah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-04-14 |
| Est. Completion | 2031-09-30 |
| Phase | Phase 2 |
What the registry record for NCT06891066 still lists
NCT06891066 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Human Immunodeficiency Virus Type 1 (HIV-1) Infection appearing as the primary indexed condition, and to 3 interventions - of which ISL is the first listed.
NCT06891066 names 20 study sites across 12 states, led by Texas, Other, California.
Frequently Asked Questions
What is clinical trial NCT06891066 about?
NCT06891066 is a clinical study titled "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)". 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 to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how m...
What is the current status of trial NCT06891066?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-04-14. Estimated completion is 2031-09-30.
What conditions does trial NCT06891066 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection.
What interventions are being tested in trial NCT06891066?
The interventions under investigation include: ISL (DRUG), ULO (DRUG), BIC/FTC/TAF (DRUG).
Who is sponsoring clinical trial NCT06891066?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06891066 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06891066's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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