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Lenacapavir

DRUG10 trials

Sponsors

Gilead Sciences Inc., Gilead Sciences, National Institute of Allergy and Infectious Diseases (NIAID), University of California, Los Angeles

Conditions

HIV InfectionsHIV PreventionHIV-1 InfectionHIV-1-infectionHuman Immunodeficiency Virushuman immunodeficiency virus type 1 (HIV-1)

Phase 1

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
CompletedNCT03739866
Gilead SciencesHIV-1 Infection
Start: 2018-11-26End: 2020-06-15Updated: 2021-04-09
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
RecruitingNCT06819176
National Institute of Allergy and Infectious Diseases (NIAID)Human Immunodeficiency Virus
Start: 2026-01-20End: 2029-01-24Target: 50Updated: 2026-10-15

Phase 2

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
Active, not recruitingNCT05502341
Gilead SciencesHIV-1-infection
Start: 2022-08-16End: 2029-12-01Updated: 2026-10-21
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Active, not recruitingNCT06532656
Gilead SciencesHIV-1-infection
Start: 2024-11-20End: 2030-12-01Target: 75Updated: 2026-09-29
Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
RecruitingNCT07841990
Gilead SciencesHIV-1 Infection
Start: 2026-10-01End: 2033-07-01Target: 125Updated: 2026-10-23
An Operationally Seamless Phase 2/3 Randomized, Open-label, 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 Treatment-Naive People With HIV-1
Not yet recruitingCTIS2026-526026-40-00
Gilead Sciences Inc.human immunodeficiency virus type 1 (HIV-1)
Target: 38Updated: 2026-10-09

Phase 3

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Active, not recruitingNCT06333808
Gilead SciencesHIV-1-infection
Start: 2024-03-25End: 2029-12-01Updated: 2026-06-15
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
RecruitingNCT07682961
Gilead SciencesHIV Infections
Start: 2026-07-14End: 2033-03-01Target: 590Updated: 2026-08-14
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
RecruitingNCT07683000
Gilead SciencesHIV-1-infection
Start: 2026-07-14End: 2033-03-01Target: 590Updated: 2026-07-30

Unknown Phase

Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County
RecruitingNCT07467018
University of California, Los AngelesHIV Prevention
Start: 2026-04-21End: 2027-12-31Target: 100Updated: 2026-04-23

Related Papers

Changing to a once-a-day single pill of bictegravir/lenacapavir from complex HIV treatment: a plain language summary of the ARTISTRY-1 study up to 1 year
Future Virology2026-09-28
The effect of antacid and mineral supplements on bictegravir pharmacokinetics: results from a Phase 1, open-label, drug-drug interaction study.
2025-11-28
Efficacy and Safety of Switching to Daily Bictegravir Plus Lenacapavir From a Complex HIV Treatment Regimen: A Randomized, Open-Label, Multicenter Phase 2 Study (ARTISTRY-1)
Clinical Infectious Diseases2024-10-304 citations