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

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

July 22, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
HIV Pre-exposure Prophylaxis
Interventions
DRUG

Lenacapavir Injection

Administered intramuscularly

DRUG

Lenacapavir Tablet

Administered orally

Trial Locations (11)

19107

RECRUITING

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center, Philadelphia

27599

NOT_YET_RECRUITING

NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill, Chapel Hill

34982

RECRUITING

Midway Immunology and Research Center, Ft. Pierce

48072

RECRUITING

Be Well Medical Center, Berkley

60613

RECRUITING

Howard Brown Health Center, Chicago

77098

RECRUITING

The Crofoot Research Center, Houston

78705

RECRUITING

Central Texas Clinical Research, Austin

90036

RECRUITING

Ruane Clinical Research Group, Inc., Los Angeles

90069

RECRUITING

Mills Clinical Research, Los Angeles

06510

RECRUITING

Yale University; School of Medicine; AIDS Program, New Haven

02215

RECRUITING

Fenway Health, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY