Study to Assess Safety and Efficacy of Lenacapavir and Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

• Status: Recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing the risk of human immunodeficiency virus (HIV) infection relative to the background HIV incidence rate.

The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a double-blind, randomized study (Randomized Phase). The Incidence Phase will include initial assessments that will provide an estimate of the concurrent background HIV incidence rate. The Randomized Phase of the study will have a Blinded Phase, a LEN Open-label Extension (OLE) Phase, and a Pharmacokinetic (PK) Tail Coverage Phase.

The primary objective for the Incidence Phase of this study is to estimate the HIV background incidence rate. The primary objectives of the Randomized Phase of this study are to evaluate the efficacy of LEN and F/TAF for HIV pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) at risk of HIV infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Key Inclusion Criteria:

• Incidence Phase

• HIV-1 status unknown at initial screening and no prior human immunodeficiency virus ( HIV)-1 testing within the last 3 months

• Sexually active (has had > 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM)

• Randomized Phase

• Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing

• Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening

• Body weight ≥ 35 kg

Key Exclusion Criteria:

• Prior receipt of an HIV vaccine

• Prior use of long-acting systemic pre-exposure prophylaxis (PrEP)

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