Lenacapavir

DRUG8 trials

Sponsors

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

Conditions

HIV InfectionsHIV PreventionHIV-1 InfectionHIV-1-infectionHuman Immunodeficiency Virus

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: 2026-07-08

Phase 2

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

Active, not recruitingNCT05502341

Gilead SciencesHIV-1-infection

Start: 2022-08-16End: 2028-07-31Updated: 2025-10-14

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: 2026-06-04

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 in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

Not yet recruitingNCT07683000

Gilead SciencesHIV-1-infection

Start: 2026-07-01End: 2033-03-01Target: 590Updated: 2026-07-06

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

Not yet recruitingNCT07682961

Gilead SciencesHIV Infections

Start: 2026-07-01End: 2033-03-01Target: 590Updated: 2026-07-06

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

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