Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention (PROPEL)

Gilead Sciences

Status

Enrolling

Conditions

HIV Infections

Treatments

Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Drug: Lenacapavir Tablet

Drug: Cabotegravir (CAB)

Drug: Emtricitabine/tenofovir alafenamide (F/TAF)

Drug: Lenacapavir Injection

Study type

Observational

Funder types

Industry

Identifiers

NCT07473778

GS-US-528-7614

Details and patient eligibility

About

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.

The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;
Willing and able to comply with all study requirements;
Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;
Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection;
After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:
1. Selects LEN PrEP as their chosen PrEP method; OR,
2. Selects a different PrEP method or chooses not to start or continue PrEP.

Key Exclusion Criteria:

Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

3,000 participants in 2 patient groups

LEN PrEP

Description:

Participants in diverse clinical settings in the United States (US) who choose subcutaneous (SC) Lenacapavir (LEN) Pre-Exposure Prophylaxis for HIV Prevention (PrEP) at enrollment in the study or anytime during the follow-up period

Treatment: