Clinical trial

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

Name

GS-US-412-5624

Description

The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.

Trial arms

Trial start

2021-08-30

Estimated PCD

2024-09-01

Trial end

2027-07-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Oral Lenacapavir (LEN)

Tablets administered orally without regard to food

Arms:

Blinded Phase: LEN + PTM F/TDF, Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF, LEN Open-Label Extension (OLE) Phase

Other names:

GS-6207

Subcutaneous (SC) Lenacapavir (LEN)

Administered via SC injections

Arms:

Blinded Phase: LEN + PTM F/TDF, Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF, LEN Open-Label Extension (OLE) Phase

Other names:

GS-6207

F/TAF

Tablets administered orally

Arms:

Blinded Phase: Placebo LEN + F/TAF

Other names:

Descovy®

F/TDF

Tablets administered orally

Arms:

Blinded Phase: Placebo LEN + F/TDF, Pharmacokinetic (PK) Tail Coverage Phase

Other names:

Truvada®

Placebo SC LEN

Administered via SC injections

Arms:

Blinded Phase: Placebo LEN + F/TAF, Blinded Phase: Placebo LEN + F/TDF

PTM Oral LEN

Tablets administered orally

Arms:

Blinded Phase: Placebo LEN + F/TAF, Blinded Phase: Placebo LEN + F/TDF

PTM F/TAF

Tablets administered orally

Arms:

Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF

PTM F/TDF

Tablets administered orally

Arms:

Blinded Phase: LEN + PTM F/TDF

Size

5368

Primary endpoint

Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY)

At Screening

Randomized Phase: HIV Incidence Reported Per 100-PY of Follow-up

When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)

Eligibility 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 HIV pre-exposure prophylaxis (PrEP) or or HIV PEP (postexposure prophylaxis). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 5368, 'type': 'ACTUAL'}}

Updated at

2024-02-28

1 organization

7 products

1 indication

Product

Lenacapavir

Indication

Pre-Exposure Prophylaxis of HIV Infection

Product

F/TAF

Product