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ACTIVE NOT RECRUITING 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)

NCT06891066 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2025-04-14
Est. Completion 2031-09-30
Phase Phase 2

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06891066

The ClinicalTrials.gov registry entry for NCT06891066 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06891066 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06891066?

The interventions under investigation include: ISL (DRUG), ULO (DRUG), BIC/FTC/TAF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06891066?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial