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ClinicalTrials.gov public records Last synced Oct 17, 2026, 12:59 AM EDT

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Showing 1–24 of 31 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Lenacapavir Clear all
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 10, 2026 · Synced Oct 17, 2026, 12:59 AM EDT
Active, not recruiting Phase 3 Interventional

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

NCT06630299
View directory record Official record
Conditions
HIV-1-Infection
Interventions
ISL/LEN, Antiretroviral Combinations
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
49
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 41 more
Source: ClinicalTrials.gov public record
Updated May 29, 2026 · Synced Oct 17, 2026, 12:59 AM 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
47
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 42 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2026 · Synced Oct 17, 2026, 12:59 AM 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 Sep 21, 2026 · Synced Oct 17, 2026, 12:59 AM EDT
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 2, 2026 · Synced Oct 17, 2026, 12:59 AM 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 24, 2026 · Synced Oct 17, 2026, 12:59 AM 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 13, 2026 · Synced Oct 17, 2026, 12:59 AM EDT
Active, not recruiting Phase 3 Interventional Accepts healthy volunteers

Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

NCT07047716
View directory record Official record
Conditions
HIV Pre-exposure Prophylaxis
Interventions
Lenacapavir Injection, Lenacapavir Tablet
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
16 Years and older
Enrollment
339 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2028
U.S. locations
31
States / cities
Birmingham, Alabama • Los Angeles, California • Palm Springs, California + 21 more
Source: ClinicalTrials.gov public record
Updated Aug 28, 2026 · Synced Oct 17, 2026, 12:59 AM 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 2, 2024 · Synced Oct 17, 2026, 12:59 AM EDT
Recruiting No phase listed Observational

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

NCT07473778
View directory record Official record
Conditions
HIV Infections
Interventions
Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF), Cabotegravir (CAB), Lenacapavir Tablet
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
3,000 participants
Timeline
2026 – 2029
U.S. locations
39
States / cities
Birmingham, Alabama • Beverly Hills, California • Los Angeles, California + 26 more
Source: ClinicalTrials.gov public record
Updated Oct 1, 2026 · Synced Oct 17, 2026, 12:59 AM 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 14, 2026 · Synced Oct 17, 2026, 12:59 AM 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 15, 2026 · Synced Oct 17, 2026, 12:59 AM 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 15, 2026 · Synced Oct 17, 2026, 12:59 AM EDT
Active, not recruiting Phase 2Phase 3 Interventional

Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

NCT06544733
View directory record Official record
Conditions
HIV-1-Infection
Interventions
Lepetegravir, Lenacapavir pacfosacil, Placebo to Match BVY, Bictegravir/emtricitabine/tenofovir alafenamide, Lepetegravir/Lenacapavir pacfosacil FDC, Placebo to Match GS1720/GS-4182 FDC
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
675 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
35
States / cities
Birmingham, Alabama • Beverly Hills, California • Los Angeles, California + 30 more
Source: ClinicalTrials.gov public record
Updated Apr 17, 2026 · Synced Oct 17, 2026, 12:59 AM EDT
Recruiting No phase listed Observational

Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County

NCT07467018
View directory record Official record
Conditions
HIV Prevention
Interventions
Community-based healthcare delivery, Lenacapavir
Other · Drug
Lead sponsor
University of California, Los Angeles
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Santa Monica, California
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Oct 17, 2026, 12:59 AM 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, Bictegravir/Lenacapavir (BIC/LEN) FDC, Bictegravir/Lenacapavir
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 Sep 29, 2026 · Synced Oct 17, 2026, 12:59 AM 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 30, 2026 · Synced Oct 17, 2026, 12:59 AM 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 30, 2026 · Synced Oct 17, 2026, 12:59 AM 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 9, 2021 · Synced Oct 17, 2026, 12:59 AM 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 27, 2026 · Synced Oct 17, 2026, 12:59 AM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP

NCT07218211
View directory record Official record
Conditions
HIV Prevention, HIV Pre-exposure Prophylaxis, HIV Prevention Program, HIV Prevention and Care, HIV Pre-exposure Prophylaxis Use
Interventions
Lenacapavir long-acting
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older · Male only
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Oct 17, 2026, 12:59 AM 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 – 2028
U.S. locations
35
States / cities
Los Angeles, California • Palm Springs, California • Sacramento, California + 28 more
Source: ClinicalTrials.gov public record
Updated Oct 1, 2026 · Synced Oct 17, 2026, 12:59 AM 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 Oct 15, 2026 · Synced Oct 17, 2026, 12:59 AM 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 28, 2025 · Synced Oct 17, 2026, 12:59 AM EDT