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RECRUITING Phase 2

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

NCT07266831 · View on ClinicalTrials.gov ↗

Study 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 lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Interventions

  • DRUG ISL
  • DRUG ULO
  • DRUG BIC/FTC/TAF
  • DRUG Placebo for BIC/FTC/TAF
  • DRUG Placebo to ISL/ULO

Study Locations (20)

Florida

  • Midway Immunology and Research Center ( Site 1503) — Ft. Pierce
  • CAN Community Health- Miami Gardens ( Site 1549) — Miami
  • Orlando Immunology Center ( Site 1501) — Orlando
  • CAN Community Health ( Site 1510) — Sarasota
  • Triple O Research Institute ( Site 1505) — West Palm Beach

Texas

  • Saint Hope Foundation, Inc. ( Site 1504) — Bellaire
  • Prism Health North Texas, Oak Cliff Health Center ( Site 1514) — Dallas
  • North Texas Infectious Diseases Consultants ( Site 1500) — Dallas
  • Texas Center for Infectious Disease Associates ( Site 1502) — Fort Worth
  • DCOL Center for Clinical Research ( Site 1511) — Longview

Georgia

  • Metro Infectious Diseases Consultants L.L.C. ( Site 1509) — Decatur
  • Mercer university, Department of internal medicine-Clinical Research ( Site 1512) — Macon

Colorado

  • Vivent Health ( Site 1519) — Denver

District of Columbia

  • Whitman-Walker Institute ( Site 1538) — Washington D.C.

Missouri

  • KC CARE Health Center ( Site 1506) — Kansas City

New Jersey

  • ID Care ( Site 1507) — Hillsborough

North Carolina

  • Regional Center for Infectious Diseases ( Site 1516) — Greensboro

Trial Details

FieldValue
Enrollment Target 570 participants
Start Date 2025-12-18
Est. Completion 2030-04-25
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 NCT07266831

The ClinicalTrials.gov registry entry for NCT07266831 describes a study currently listed as 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 570 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 5 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: NCT07266831 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Texas, Georgia. 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 NCT07266831 about?

NCT07266831 is a clinical study titled "A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)". 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 lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take u...

What is the current status of trial NCT07266831?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 570 participants. The study started on 2025-12-18. Estimated completion is 2030-04-25.

What conditions does trial NCT07266831 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 NCT07266831?

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

Who is sponsoring clinical trial NCT07266831?

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 NCT07266831 being conducted?

This trial has 20 study locations across Colorado, 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