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Weekly HIV pill could replace daily doses

NCT ID NCT05052996

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if a once-weekly combination of two oral drugs, islatravir and lenacapavir, can keep HIV under control in people whose virus is already suppressed. 142 participants switched from their daily HIV pill to this weekly regimen. The main goal is to see if the virus stays undetectable after 24 weeks. This is not a cure, but aims to make HIV management easier with fewer doses.

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

142 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Mar 2028

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: * Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening. * Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening. * Plasma HIV-1 RNA \< 50 copies/mL at screening. Key Exclusion Criteria: * History of prior virologic failure while receiving treatment for HIV-1. * Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN). * Active, serious infections requiring parenteral therapy \< 30 days before randomization. * Active or occult hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory. * Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. * Any of the following laboratory values at screening: * Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula * CD4+ T-cells \< 200 cells/mm\^3 (Cohort 1); CD4+ T-cells \< 350 cells/mm\^3 (cohort 2). * Absolute lymphocyte count \< 900 cells/mm\^3 (cohort 2). * Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration. * Individuals who plan to continue breastfeeding during the study. * Documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs) resistance mutations in reverse transcriptase, including M184V/I (Cohort 2). 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 Arms Inc

    Dallas, Texas, 75208, United States

  • AXCES Research Group

    Santa Fe, New Mexico, 87505, United States

  • AccessHealth MA

    Boston, Massachusetts, 02129, United States

  • Atlanta ID Group, PC

    Atlanta, Georgia, 30309, United States

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CAN Community Health Care, Inc.

    Fort Lauderdale, Florida, 33316, United States

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705, United States

  • Chatham County Health Department

    Savannah, Georgia, 31401, United States

  • Community Health Care

    Tacoma, Washington, 98405, United States

  • Emory University Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308, United States

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Hennepin Healthcare HCMC

    New Brighton, Minnesota, 55112, United States

  • Hoag Medical Group - Newport Beach

    Newport Beach, California, 92663, United States

  • Howard Brown Health Center

    Chicago, Illinois, 60613, United States

  • Huntridge Family Clinic

    Las Vegas, Nevada, 89104, United States

  • ID Care

    Hillsborough, New Jersey, 08844, United States

  • Indiana CTSI Clinical Research Center

    Indianapolis, Indiana, 46202, United States

  • JEM Research Institute

    Lake Worth, Florida, 33462, United States

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako

    Honolulu, Hawaii, 96813, United States

  • Metro Infectious Disease Consultants

    Decatur, Georgia, 30033, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, United States

  • MultiCare Rockwood Main Clinic

    Spokane, Washington, 99202, United States

  • NC TraCS Institute - CTRC: University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • New York-Presbyterian Queens

    Flushing, New York, 11355, United States

  • North Texas Infectious Diseases Consultants, P.A.

    Dallas, Texas, 75246, United States

  • Northstar Healthcare

    Chicago, Illinois, 60657, United States

  • Optimus Medical Group

    San Francisco, California, 94102, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211, United States

  • Penn Medicine: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Peter Shalit, M.D.

    Seattle, Washington, 98104, United States

  • Philadelphia FIGHT Community Health Centers

    Philadelphia, Pennsylvania, 19107, United States

  • Public Health Institute at Denver Health

    Denver, Colorado, 80204, United States

  • Ruane Clinical Research Group, Inc

    Los Angeles, California, 90036, United States

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136, United States

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139, United States

  • The Crofoot Research Center, INC

    Houston, Texas, 77098, United States

  • The George Washington University Medical Faculty Associates Inc.

    Washington D.C., District of Columbia, 20037, United States

  • Vivent Health

    Denver, Colorado, 80246, United States

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017, United States

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