Could a shot replace daily HIV pills? new trial tests Two-Injection combo

NCT ID NCT07645287

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

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This Phase 2 trial tests whether switching to a combination of two injectable drugs, GS-3242 and lenacapavir, works as well as staying on the daily pill Biktarvy for people with HIV who already have the virus under control. About 175 participants will be randomly assigned to either the injectable regimen or continue their current pill. The main goal is to see if the injectable keeps the virus suppressed at 35 weeks (Part A) and 26 weeks (Part B).

What this could mean

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

Active substance: GS-3242 and lenacapavir (injectable drugs)
What this could lead to: If successful, this could offer people with HIV a long-acting injectable alternative to daily pills, making treatment easier and more private.
What could go wrong: This is an early Phase 2 trial with only 175 participants. The injectable regimen may not keep the virus suppressed as well as the daily pill, and side effects from the injections are possible.

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

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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

AHF - Pensacola
RECRUITING

Pensacola, Florida, 32504, United States
AIDS Healthcare Foundation -Coconut Grove
RECRUITING

Miami, Florida, 33133, United States
AXCES Research Group, LLC
RECRUITING

Santa Fe, New Mexico, 87505, United States
Be Well Medical Center
RECRUITING

Berkley, Michigan, 48072, United States
Brooklyn Clinical Research
RECRUITING

Brooklyn, New York, 11226, United States
CAN Community Health Fort Lauderdale
RECRUITING

Fort Lauderdale, Florida, 33316, United States
CAN Community Health Inc.
RECRUITING

Sarasota, Florida, 34237, United States
Central Texas Clinical Research
RECRUITING

Austin, Texas, 78705, United States
Chatham County Health Department
RECRUITING

Savannah, Georgia, 31401, United States
Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID
RECRUITING

Annandale, Virginia, 22003, United States
Clinical Research Puerto Rico
RECRUITING

San Juan, PR, 00909, Puerto Rico
Diagnostic Clinic of Longview
RECRUITING

Longview, Texas, 75605, United States
East Sydney Doctors
RECRUITING

Sydney, New South Wales, 2010, Australia
ID care
RECRUITING

Hillsborough, New Jersey, 08844, United States
KC CARE Health Center
RECRUITING

Kansas City, Missouri, 64111, United States
Mercer University, Department of Internal Medicine
RECRUITING

Macon, Georgia, 31201, United States
Metro Infectious Disease Consultants, P.L.L.C.
RECRUITING

Decatur, Georgia, 30033, United States
Midland Florida Clinical Research Center, LLC
RECRUITING

DeLand, Florida, 32720, United States
Midway Immunology and Research Center
RECRUITING

Ft. Pierce, Florida, 34982, United States
Momentum Clinical Research Darlinghurst
RECRUITING

Sydney, New South Wales, 2010 NSW, Australia
North Texas Infectious Disease Consultants, P.A.
RECRUITING

Dallas, Texas, 75246, United States
Optimus Medical Group
RECRUITING

San Francisco, California, 94102, United States
Pacific Oak Medical Group
RECRUITING

Beverly Hills, California, 90211, United States
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Prahran Market Clinic,
RECRUITING

South Yarra, Victoria, 3141, Australia
Prism Health North Texas
RECRUITING

Dallas, Texas, 75208, United States
Rosedale Health and Wellness
RECRUITING

Huntersville, North Carolina, 28078, United States
South Jersey Infectious Disease
RECRUITING

Somers Point, New Jersey, 08244, United States
Southampton Community Healthcare
RECRUITING

St Louis, Missouri, 63139, United States
Spectrum Health
ACTIVE_NOT_RECRUITING

Vancouver, V6Z2T1, Canada
St. Hope Foundation
RECRUITING

Bellaire, Texas, 77401, United States
Taylor Square Private Clinic
RECRUITING

Surry Hills, New South Wales, 2010, Australia
The Crofoot Research Center, INC.
RECRUITING

Houston, Texas, 77098, United States
TribalMed PLLC
RECRUITING

Seattle, Washington, 98104, United States
Triple O Research Institute, PA
RECRUITING

West Palm Beach, Florida, 33407, United States
University of California San Francisco, Community and Clinical Research Center
RECRUITING

San Francisco, California, 94110, United States

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