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PURPOSE 1

Status
Ongoing
Phase
III
Objective


Gilead's lenacapavir trials are resumed as of May 2022. See Gilead’s press release on the release of FDA's clinical hold.

Trial was on clinical hold due to concerns about compatibility of the glass vials with the lenacapavir solution. See Gilead’s press release on the clinical hold in December 2021.


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.

Last updated September 20, 2022

Prevention Option(s)
Combination Prevention
Study Design
Randomized
Blind
Arms and Assigned Interventions
Description
Experimental: Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF Participants will receive the following for at least 52 weeks: Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks Oral PTM Emtricitabine/Tenofovir Alafenamide (F/TAF) once daily Oral LEN 600 mg on Days 1 and 2 Drug: Oral Lenacapavir (LEN) Tablets administered orally without regard to food Other Name: GS-6207 Drug: Subcutaneous (SC) Lenacapavir (LEN) Administered via SC injections Other Name: GS-6207 Drug: PTM F/TAF Tablets administered orally
Mode of Delivery
Subcutaneous
Tablet
Products
F/TAF
Lenacapavir
ARMs
Experimental
Description
Experimental: Blinded Phase: LEN + PTM F/TDF Participants will receive the following for at least 52 weeks: SC LEN 927 mg every 26 weeks Oral PTM Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) once daily Oral LEN 600 mg on Days 1 and 2 Drug: Oral Lenacapavir (LEN) Tablets administered orally without regard to food Other Name: GS-6207 Drug: Subcutaneous (SC) Lenacapavir (LEN) Administered via SC injections Other Name: GS-6207 Drug: PTM F/TDF Tablets administered orally
Mode of Delivery
Subcutaneous
Tablet
Products
F/TDF
Lenacapavir
ARMs
Experimental
Description
Experimental: Blinded Phase: Placebo LEN + F/TAF Participants will receive the following for at least 52 weeks: SC placebo LEN every 26 weeks Oral F/TAF 200/25 mg once daily Oral PTM LEN on Days 1 and 2 Drug: F/TAF Tablets administered orally Other Name: Descovy® Drug: Placebo SC LEN Administered via SC injections Drug: PTM Oral LEN Tablets administered orally
Mode of Delivery
Subcutaneous
Tablet
Products
F/TAF
ARMs
Experimental
Description
Experimental: LEN Open-Label Extension (OLE) Phase After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase. Participants randomized to LEN will continue to receive SC LEN 927 mg every 26 weeks for a total of 2 doses. Participants randomized to F/TAF or F/TDF will receive SC LEN 927 mg on OLE Day 1 and OLE Week 26, and will also receive oral LEN 600 mg on OLE Days 1 and 2. Drug: Oral Lenacapavir (LEN) Tablets administered orally without regard to food Other Name: GS-6207 Drug: Subcutaneous (SC) Lenacapavir (LEN) Administered via SC injections Other Name: GS-6207
Mode of Delivery
Subcutaneous
Tablet
Products
Lenacapavir
ARMs
Experimental
Description
Experimental: Pharmacokinetic (PK) Tail Coverage Phase At the completion of the LEN OLE phase, participants will transition into the PK Tail Coverage phase. Additionally, participants that either prematurely discontinue the study drug during the blinded phase or choose not to continue in the LEN OLE phase (if randomized to LEN in the blinded phase) or who discontinue the study drug in the LEN OLE phase are also eligible to transition to the PK Tail Coverage phase. Participants will receive oral F/TDF once daily for 78 weeks beginning 26 weeks after the last LEN injection. Drug: F/TDF Tablets administered orally Other Name: Truvada®
Mode of Delivery
Tablet
Products
F/TDF
ARMs
Experimental
Trial Sponsors
Gilead Sciences
August 2021
July 2027
Enrollment
5 010
16
Years
25
Years
Population
Women
Sites

Madibeng Centre for Research

Brits
South Africa

Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg
South Africa