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These results were retrieved from the live ClinicalTrials.gov registry. Filters and sort order apply to this result list.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 2:23 AM EDT

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

Showing 1–14 of 14 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Bictegravir/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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 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, 2:23 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

NCT05052996
View directory record Official record
Conditions
HIV-1 Infection
Interventions
ISL, LEN, B/F/TAF, ISL/LEN FDC
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
142 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2028
U.S. locations
44
States / cities
Beverly Hills, California • Los Angeles, California • Newport Beach, California + 33 more
Source: ClinicalTrials.gov public record
Updated Feb 4, 2026 · Synced Oct 17, 2026, 2:23 AM 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
12
States / cities
Torrance, California • New Haven, Connecticut • Ft. Pierce, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 17, 2026, 2:23 AM EDT