RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.

Official Title

A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP

Quick Facts

Study Start:2025-07-25

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07047716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* At least 16 years of age at screening. * Receptive anal or vaginal sex in the past 6 months and at least 1 of the following: 1. Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months 2. For a person who has engaged in anal sex in the past 6 months: diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months 3. For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months 4. Sex with partner known to be living with HIV with an unknown or detectable viral load in the past 6 months * Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.	* Current signs or symptoms suggesting HIV infection * Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection * Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding) * Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product) * Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months

Inclusion Criteria

Exclusion Criteria

* At least 16 years of age at screening.
* Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:
1. Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months
2. For a person who has engaged in anal sex in the past 6 months: diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months
3. For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months
4. Sex with partner known to be living with HIV with an unknown or detectable viral load in the past 6 months
* Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.

* Current signs or symptoms suggesting HIV infection
* Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
* Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)
* Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product)
* Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

Mills Clinical Research

Los Angeles, California, 90069

United States

Midway Immunology and Research Center

Fort Pierce, Florida, 34982

United States

The Crofoot Research Center

Houston, Texas, 77098

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-25

Study Completion Date2028-09

Study Record Updates

Study Start Date2025-07-25

Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

HIV Pre-exposure Prophylaxis