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ClinicalTrials.gov public records Last synced Sep 1, 2026, 1:44 PM EDT

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Showing 1–24 of 31 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Lenacapavir Clear all
Active, not recruiting Phase 4 Interventional Accepts healthy volunteers

Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting

NCT07210125
View directory record Official record
Conditions
HIV
Interventions
Lenacapavir long-acting, Standard of Care (SOC)
Drug · Other
Lead sponsor
Kelley-Ross & Associates, Inc.
Other
Eligibility
18 Years and older
Enrollment
75 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2027
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Apr 1, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 1 Interventional Accepts healthy volunteers

A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

NCT06970223
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir long-acting, Lenacapavir long-acting
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
65 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
Long Beach, California
Source: ClinicalTrials.gov public record
Updated Nov 27, 2025 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

NCT04143594
View directory record Official record
Conditions
HIV-1-infection
Interventions
Oral Lenacapavir, F/TAF, Subcutaneous Lenacapavir, TAF, BIC, B/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
183 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
49
States / cities
Phoenix, Arizona • Los Angeles, California • Palm Springs, California + 40 more
Source: ClinicalTrials.gov public record
Updated Oct 1, 2024 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

NCT06532656
View directory record Official record
Conditions
HIV-1-infection
Interventions
Lenacapavir, BIC/LEN FDC
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
2 Years to 17 Years
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
4
States / cities
Washington D.C., District of Columbia • Tampa, Florida • Atlanta, Georgia + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 2 Interventional

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

NCT07645287
View directory record Official record
Conditions
HIV-1-infection
Interventions
GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection, B/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
175 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
30
States / cities
Beverly Hills, California • San Francisco, California • DeLand, Florida + 25 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Results available

Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

NCT04811040
View directory record Official record
Conditions
HIV-1 Infection
Interventions
Oral Lenacapavir, Subcutaneous Lenacapavir, Teropavimab, Zinlirvimab
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years to 65 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
23
States / cities
Los Angeles, California • Sacramento, California • San Diego, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jan 26, 2025 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

NCT06101329
View directory record Official record
Conditions
Pre-Exposure Prophylaxis of HIV Infection
Interventions
Lenacapavir Tablet, Lenacapavir Injection, Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older · Female only
Enrollment
253 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2028
U.S. locations
11
States / cities
Birmingham, Alabama • San Diego, California • Washington D.C., District of Columbia + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 3 Interventional

Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

NCT07682961
View directory record Official record
Conditions
HIV Infections
Interventions
Lenacapavir, Lenacapavir Tablet, Teropavimab, Zinlirvimab, Cabotegravir, Rilpivirine
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
590 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
16
States / cities
San Francisco, California • DeLand, Florida • Fort Lauderdale, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 1 Interventional

Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy

NCT06819176
View directory record Official record
Conditions
Human Immunodeficiency Virus
Interventions
Lenacapavir
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 75 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2 Interventional Results available

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

NCT05729568
View directory record Official record
Conditions
HIV-1 Infection
Interventions
Teropavimab, Zinlirvimab, Lenacapavir Tablet, Lenacapavir Injection, Antiretroviral Therapy
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years to 65 Years
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
29
States / cities
Los Angeles, California • San Diego, California • San Francisco, California + 25 more
Source: ClinicalTrials.gov public record
Updated Apr 26, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Terminated Phase 2Phase 3 Interventional

Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

NCT06613685
View directory record Official record
Conditions
HIV-1-infection
Interventions
lepetegravir, lenacapavir pacfosacil, Bictegravir/emtricitabine/tenofovir alafenamide, lepetegravir/lenacapavir pacfosacil FDC, Placebo to Match BVY, Placebo to Match GS1720/GS-4182 FDC
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
73 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
21
States / cities
Birmingham, Alabama • Torrance, California • West Hollywood, California + 17 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 3 Interventional

Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

NCT07683000
View directory record Official record
Conditions
HIV-1-infection
Interventions
Lenacapavir, Lenacapavir Tablet, Teropavimab, Zinlirvimab, SBR
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
590 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
2
States / cities
Berkeley, Michigan • Annandale, Virginia
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Not yet recruiting Not applicable Interventional Accepts healthy volunteers

PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence

NCT07335289
View directory record Official record
Conditions
HIV Pre-exposure Prophylaxis Use
Interventions
Choice of follow up, Follow up via standard clinic
Other
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older
Enrollment
400 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 24, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting No phase listed Observational

HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots

NCT04979728
View directory record Official record
Conditions
HIV Treatment, HIV Prevention
Interventions
At Home Self-Collections
Other
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Mar 2, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional Results available

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

NCT04150068
View directory record Official record
Conditions
HIV-1-infection
Interventions
Oral Lenacapavir, Oral Lenacapavir Placebo, Subcutaneous Lenacapavir, Failing ARV Regimen, Optimized Background Regimen (OBR)
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
12 Years and older
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
35
States / cities
Los Angeles, California • Palm Springs, California • Sacramento, California + 28 more
Source: ClinicalTrials.gov public record
Updated Mar 12, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 3 Interventional Accepts healthy volunteers Results available

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

NCT04925752
View directory record Official record
Conditions
Pre-Exposure Prophylaxis of HIV Infection
Interventions
Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF, PTM Oral LEN, F/TAF (for US participants only)
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
16 Years and older
Enrollment
3,292 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2028
U.S. locations
60
States / cities
Birmingham, Alabama • Loma Linda, California • Los Angeles, California + 43 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 2 Interventional

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

NCT06749054
View directory record Official record
Conditions
HIV-1-infection
Interventions
Oral Lenacapavir, Subcutaneous Lenacapavir, Optimized Background Regimen (OBR)
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
Up to 17 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

NCT05502341
View directory record Official record
Conditions
HIV-1-infection
Interventions
Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
689 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
40
States / cities
Berkeley, California • Beverly Hills, California • Los Angeles, California + 34 more
Source: ClinicalTrials.gov public record
Updated Aug 9, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

NCT06101342
View directory record Official record
Conditions
Pre-Exposure Prophylaxis of HIV Infection
Interventions
Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
181 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2028
U.S. locations
9
States / cities
Los Angeles, California • San Diego, California • Miami, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Aug 12, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 3 Interventional

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

NCT06630286
View directory record Official record
Conditions
HIV-1-infection
Interventions
ISL/LEN, B/F/TAF, PTM B/F/TAF, PTM ISL/LEN
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
609 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
60
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 50 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 2Phase 3 Interventional

Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

NCT07708727
View directory record Official record
Conditions
HIV-1-infection
Interventions
GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection, B/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
700 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
7
States / cities
Ft. Pierce, Florida • West Palm Beach, Florida • Decatur, Georgia + 3 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 3 Interventional

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

NCT06333808
View directory record Official record
Conditions
HIV-1-infection
Interventions
Bictegravir, Lenacapavir, B/F/TAF, Placebo to match B/F/TAF, Placebo to match BIC/LEN
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
577 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
51
States / cities
Phoenix, Arizona • Berkeley, California • Beverly Hills, California + 43 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

The TAIL-PrEP Study

NCT06868641
View directory record Official record
Conditions
HIV Infections
Interventions
TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing LEN
Behavioral
Lead sponsor
Columbia University
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 27, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Results available

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults

NCT03739866
View directory record Official record
Conditions
HIV-1 Infection
Interventions
Lenacapavir, Placebo, B/F/TAF, TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years to 65 Years
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
12
States / cities
Los Angeles, California • Sacramento, California • Torrance, California + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 8, 2021 · Synced Sep 1, 2026, 1:44 PM EDT