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New weekly treatment for HIV-1 in adults

A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT06891066

This study is testing a new weekly HIV treatment to see if it works as well as the standard daily medication for adults who are already managing their virus.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations21 sites (San Francisco, California and 20 other locations)
Trial IDNCT06891066 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a new treatment regimen combining Islatravir (ISL) and Ulonivirine (ULO) taken once weekly in adults who are virologically suppressed with HIV-1. Participants will be compared to those receiving the standard daily treatment of Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF). The primary goal is to determine the proportion of participants maintaining viral suppression after 24 weeks, while also assessing the safety and tolerability of the new treatment. The study aims to provide insights into more convenient treatment options for individuals living with HIV-1.

Who should consider this trial

Good fit: Ideal candidates are adults who have been on a stable regimen of BIC/FTC/TAF with documented viral suppression for at least six months.

Not a fit: Patients with HIV-2 infection, active AIDS-defining opportunistic infections, or significant coinfections such as hepatitis B or C may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more convenient weekly option for managing HIV-1, improving adherence and quality of life for patients.

How similar studies have performed: Other studies have shown promise in exploring less frequent dosing regimens for HIV treatment, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

San Francisco, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Human Immunodeficiency Virus Type 1 InfectionHIV-1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.