PURPOSE 2

Status:Ongoing
Phase:III
Principal Investigator(s):
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) 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 objective of the Randomized Phase of this study is to evaluate the efficacy of lenacapavir for HIV pre-exposure prophylaxis (PrEP) in cisgender men (CGM), transgender women (TGW), transgender men (TGM), and gender nonbinary people (GNB) ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection. Last updated May 17, 2022
Prevention Option(s):PrEP
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF Participants will receive the following for at least 52 weeks: Subcutaneous (SC) lenacapavir (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: Sub-cutaneous (SC) Lenacapavir (LEN) Administered via SC injections Other Name: GS-6207 Drug: PTM F/TDF Tablets administered orally
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: 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/TDF will receive SC LEN 927 mg on OLE Day 1, OLE Week 26, and OLE Week 52 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: Sub-cutaneous (SC) Lenacapavir (LEN) Administered via SC injections Other Name: GS-6207
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: PK Tail Coverage Phase At the completion of the LEN OLE phase, participants will transition into the PK Tail Coverage phase. Additionally, participants that prematurely discontinue the study drug during blinded phase and participants that were randomized to LEN who choose not to continue 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 injection of LEN. Drug: F/TDF Tablets administered orally Other Name: Truvada®
Mode of DeliveryTablet
ARMsExperimental
Official Code: NCT04925752
Trial Sponsors: Gilead
Start Date
End Date
June 14, 2021
April 1, 2027
Enrollment:3,000
Age range: 16 Years ↔ any
Population:Cisgender Men, Gay and Bisexual Men Who Have Sex with Men, Transgender Men, Transgender Women