Once-weekly islatravir plus ulonivirine for people with untreated HIV-1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 study enrolls ART‑naïve adults with HIV-1 and compares a once-weekly oral regimen of islatravir plus ulonivirine to a standard once-daily antiretroviral regimen (bictegravir/emtricitabine/tenofovir alafenamide). Participants are randomized and receive matching placebos as needed to maintain blinding. Primary goals include measuring viral suppression rates and characterizing safety and tolerability over time. The trial excludes people with HIV-2, active hepatitis B or C, recent malignancy, or AIDS-defining opportunistic infections.

Why it matters

Who can join: the full rules

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 and ≤1,000,000 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.

Where it's running

• Ruane Clinical Research Group, Inc. ( Site 1513)
  Los Angeles, California, United States Recruiting
• Vivent Health ( Site 1519)
  Denver, Colorado, United States Recruiting
• Whitman-Walker Institute ( Site 1538)
  Washington D.C., District of Columbia, United States Recruiting
• Midway Immunology and Research Center ( Site 1503)
  Ft. Pierce, Florida, United States Recruiting
• CAN Community Health- Miami Gardens ( Site 1549)
  Miami Gardens, Florida, United States Recruiting
• Orlando Immunology Center ( Site 1501)
  Orlando, Florida, United States Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.