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Weekly HIV pill could replace daily dosing

NCT ID NCT06544733

Disease control Sponsor: Gilead Sciences 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a new once-weekly oral combination of two experimental drugs, lepetegravir and lenacapavir pacfosacil, can keep HIV under control as well as the daily pill Biktarvy. About 675 adults with already-suppressed HIV will take either the weekly combo or continue Biktarvy. The goal is to see if the weekly option is safe and effective at maintaining viral suppression.

What this could mean

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

Active substance
lepetegravir (GS-1720) and lenacapavir pacfosacil (GS-4182) combination
What this could lead to
If successful, this could offer people with HIV a convenient once-weekly pill option instead of daily medication, potentially improving adherence and quality of life.
What could go wrong
This is an early-to-mid stage trial (Phase 2/3) with 675 participants, so results may not confirm long-term safety or efficacy. There is also a risk that the weekly regimen may not suppress the virus as well as the daily standard of care.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 675 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

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.

Key Inclusion Criteria: * Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 24 weeks before and at screening. * Receiving BVY for ≥ 24 weeks prior to screening. Key Exclusion Criteria: * Prior use of, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil. * History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen. * Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene. * Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine. * Any of the following laboratory values at screening: * Clusters of differentiation 4 (CD4) cell count \< 200 cells/mm\^3 at screening * Glomerular filtration rate \< 60 mL/min according to the Modification of Diet in Renal Disease formula * Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 1.5 × upper limit of normal (ULN) * Direct bilirubin \> 1.5 × ULN * Platelets count \< 50,000 cells/mm\^3 * Hemoglobin \< 8.0 g/dL * Active or occult hepatitis B virus (HBV) infection. * Active hepatitis C virus (HCV). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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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

  • AIDS Healthcare Foundation - The Kinder Medical Group

    Miami, Florida, 33133, United States

  • AXCES Research Group, LLC

    Santa Fe, New Mexico, 87505, United States

  • AXCES Research Group, LLC

    El Paso, Texas, 79902, United States

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • CAN Community Health

    Fort Lauderdale, Florida, 33316, United States

  • CAN Community Health

    Sarasota, Florida, 34237, United States

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Centro Ararat, Inc.

    San Juan, PR, 00717, Puerto Rico

  • Chatham County Health Department

    Savannah, Georgia, 31401, United States

  • Clinical Research Puerto Rico

    San Juan, PR, 00909-1711, Puerto Rico

  • DCOL Center for Clinical Research

    Longview, Texas, 75605, United States

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • HOPE Clinical Research

    San Juan, PR, 00909, Puerto Rico

  • KC CARE Health Center

    Kansas City, Missouri, 64111, United States

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Mercer University, Department of Internal Medicine

    Macon, Georgia, 31201, United States

  • Metro Infectious Disease Consultants, P.L.L.C.

    Decatur, Georgia, 30033, United States

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720, United States

  • Midway and Immunology Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, United States

  • NYU Langone Health Vaccine Center

    New York, New York, 10016, United States

  • NewYork-Presbyterian Queens

    Flushing, New York, 11355, United States

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211, United States

  • Peter Shalit, MD

    Seattle, Washington, 98104, United States

  • Prism Health North Texas, Oak Cliff Health Center

    Dallas, Texas, 75215, United States

  • Proyecto ACTC

    San Juan, PR, 00935, Puerto Rico

  • Rosedale Health and Wellness

    Huntersville, North Carolina, 28078, United States

  • Ruane Clinical Research Group

    Los Angeles, California, 90036, United States

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • St Hope Foundation, Inc.

    Bellaire, Texas, 77401, United States

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104, United States

  • The Crofoot Research Center, INC.

    Houston, Texas, 77098, United States

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407, United States

  • UAB 1917 Research Clinic

    Birmingham, Alabama, 35294, United States

  • UCSF Division of HIV, Infectious Diseases & Global Medicine

    San Francisco, California, 94110, United States

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