A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

ClinicalTrials.gov ID: NCT07645287

Public ClinicalTrials.gov record NCT07645287. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Study identification

NCT ID: NCT07645287
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Gilead Sciences; Industry
Enrollment: 175 participants

Conditions and interventions

Conditions

HIV-1-infection

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 14, 2026
Primary completion: Jul 31, 2027
Completion: Mar 31, 2033
Last update posted: Aug 5, 2026

2026 – 2033

United States locations

U.S. sites: 30
U.S. states: 13
U.S. cities: 28

Facility	City	State	ZIP	Site status
Pacific Oak Medical Group	Beverly Hills	California	90211	Recruiting
Optimus Medical Group	San Francisco	California	94102	Recruiting
University of California San Francisco, Community and Clinical Research Center	San Francisco	California	94110	Recruiting
Midland Florida Clinical Research Center, LLC	DeLand	Florida	32720	Recruiting
CAN Community Health Fort Lauderdale	Fort Lauderdale	Florida	33316	Recruiting
Midway Immunology and Research Center	Ft. Pierce	Florida	34982	Recruiting
AIDS Healthcare Foundation -Coconut Grove	Miami	Florida	33133	Recruiting
AHF - Pensacola	Pensacola	Florida	32504	Recruiting
CAN Community Health Inc.	Sarasota	Florida	34237	Recruiting
Triple O Research Institute, PA	West Palm Beach	Florida	33407	Recruiting
Metro Infectious Disease Consultants, P.L.L.C.	Decatur	Georgia	30033	Recruiting
Mercer University, Department of Internal Medicine	Macon	Georgia	31201	Recruiting
Chatham County Health Department	Savannah	Georgia	31401	Recruiting
Be Well Medical Center	Berkley	Michigan	48072	Recruiting
KC CARE Health Center	Kansas City	Missouri	64111	Recruiting
Southampton Community Healthcare	St Louis	Missouri	63139	Recruiting
ID care	Hillsborough	New Jersey	08844	Recruiting
South Jersey Infectious Disease	Somers Point	New Jersey	08244	Recruiting
AXCES Research Group, LLC	Santa Fe	New Mexico	87505	Recruiting
Brooklyn Clinical Research	Brooklyn	New York	11226	Recruiting
Rosedale Health and Wellness	Huntersville	North Carolina	28078	Recruiting
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center	Philadelphia	Pennsylvania	19107	Recruiting
Central Texas Clinical Research	Austin	Texas	78705	Recruiting
St. Hope Foundation	Bellaire	Texas	77401	Recruiting
Prism Health North Texas	Dallas	Texas	75208	Recruiting
North Texas Infectious Disease Consultants, P.A.	Dallas	Texas	75246	Recruiting
The Crofoot Research Center, INC.	Houston	Texas	77098	Recruiting
Diagnostic Clinic of Longview	Longview	Texas	75605	Recruiting
Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID	Annandale	Virginia	22003	Recruiting
TribalMed PLLC	Seattle	Washington	98104	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07645287, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 5, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07645287 live on ClinicalTrials.gov.

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