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Weekly HIV pill could replace daily doses

NCT ID NCT04564547

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether switching from a daily HIV pill (Biktarvy) to a once-weekly combination of two experimental drugs (islatravir and ulonivirine) is safe and tolerable. It involved 161 adults whose HIV was already well-controlled on daily therapy. The goal was to see if a weekly regimen could keep the virus suppressed with fewer daily doses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Islatravir and ulonivirine (two experimental drugs taken together once a week)
What this could lead to
If successful, this could lead to a once-weekly pill regimen for HIV, making it easier for people to stay on treatment and keep the virus under control.
What could go wrong
This is an early phase 2b trial with only 161 participants, so results may not apply to everyone. The drugs may cause side effects or fail to keep the virus suppressed as well as current daily pills.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

161 people

The number who actually took part.

Started

Mar 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is HIV-1 positive with plasma human immunodeficiency virus type 1 (HIV-1) RNA \<50 copies/mL at screening * Has been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for ≥6 months * Has a screening CD4+ T-cell count \>200 cells/mm\^3 (completed by the central laboratory) * Is male or female, at least 18 years of age, at the time of signing the informed consent * Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: * Is not a woman of childbearing potential (WOCBP) * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) Exclusion Criteria: * Has HIV-2 infection * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive) * Has a current (active) diagnosis of acute hepatitis due to any cause * Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma * Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies * Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period * Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI) * Is female and expecting to conceive or donate eggs at any time during the study

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • CHU Hotel Dieu Nantes ( Site 2310)

    Nantes, Loire-Atlantique, 44093, France

  • CHU de Toulouse - Hopital Purpan ( Site 2302)

    Toulouse, Haute-Garonne, 31059, France

  • CHUV (centre hospitalier universitaire vaudois) ( Site 2605)

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centre Hospitalier Regional du Orleans ( Site 2304)

    Orléans, Loiret, 45100, France

  • Chatham County Health Department ( Site 2707)

    Savannah, Georgia, 31410, United States

  • DCOL Center for Clinical Research ( Site 2715)

    Longview, Texas, 75605, United States

  • Hopital Avicenne ( Site 2305)

    Bobigny, Seine-Saint-Denis, 93000, France

  • Hopital Gui de Chauliac. ( Site 2303)

    Montpellier, Herault, 34295, France

  • Hopital Saint Louis ( Site 2308)

    Paris, 75010, France

  • Hopital Saint-Antoine ( Site 2307)

    Paris, 75012, France

  • Hopitaux Universitaires de Geneve HUG ( Site 2604)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Infectious Disease Specialists Of Atlanta PC ( Site 2704)

    Decatur, Georgia, 30033, United States

  • Inselspital Universitaetsspital Bern ( Site 2603)

    Bern, Canton of Bern, 3010, Switzerland

  • Kansas City CARE Clinic ( Site 2703)

    Kansas City, Missouri, 64111, United States

  • Men's Health Foundation ( Site 2710)

    Los Angeles, California, 90069, United States

  • Midway Immunology and Research ( Site 2713)

    Ft. Pierce, Florida, 34982, United States

  • Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306)

    Paris, Île-de-France Region, 75013, France

  • Pueblo Family Physicians ( Site 2702)

    Phoenix, Arizona, 85015, United States

  • Saint Hope Foundation, Inc. ( Site 2716)

    Bellaire, Texas, 77401, United States

  • Texas Centers for Infectious Disease Associates P.A. ( Site 2709)

    Fort Worth, Texas, 76104, United States

  • Triple O Research Institute, P.A. ( Site 2712)

    West Palm Beach, Florida, 33407, United States

  • Universitaetsspital Basel ( Site 2602)

    Basel, Canton of Basel-City, 4031, Switzerland

  • Universitaetsspital Zuerich ( Site 2601)

    Zuerich, Canton of Aargau, 8091, Switzerland

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