Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1)

Gilead Sciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Treatments: Drug: Placebo SC LEN; Drug: F/TDF; Drug: Subcutaneous (SC) Lenacapavir (LEN); Drug: F/TAF; Drug: PTM F/TDF; Drug: PTM F/TAF; Drug: PTM Oral LEN; Drug: Oral Lenacapavir (LEN)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04994509

DOH-27- 072021-6125 (Registry Identifier)

GS-US-412-5624

Details and patient eligibility

About

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

The primary objective of this study is to evaluate the efficacy of LEN and F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.

Enrollment: 5,368 patients

Sex: Female

Ages: 16 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 any long-acting systemic HIV pre-exposure prophylaxis (PrEP) or prior HIV postexposure prophylaxis (PEP) in the past 12 weeks.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5,368 participants in 5 patient groups

Randomized Blinded Phase: Lenacapavir

Experimental group

Description:

Participants will receive lenacapavir (LEN) 927 mg injection, every 26 weeks starting on Day 1 for up to approximately 52 weeks. Participants will also receive loading dose of LEN 600 mg, tablet, once daily on Day 1 and Day 2. Participants will receive placebo to match (PTM) emtricitabine/tenofovir disoproxil fumarate (F/TDF) or PTM emtricitabine/tenofovir alafenamide (F/TAF), once daily, up to approximately 52 weeks.

Treatment:

Drug: Oral Lenacapavir (LEN)

Drug: PTM F/TAF

Drug: PTM F/TDF

Drug: Subcutaneous (SC) Lenacapavir (LEN)

Randomized Blinded Phase: F/TAF

Experimental group

Description:

Participants will receive F/TAF, once daily up to approximately 52 weeks. Participants will also receive PTM LEN injection, every 26 weeks, starting on Day 1 up to approximately 52 weeks. Participants will receive PTM LEN tablet, once daily on Day 1 and Day 2.

Treatment:

Drug: PTM Oral LEN

Drug: F/TAF

Drug: Placebo SC LEN

Randomized Blinded Phase: F/TDF

Experimental group

Description:

Participants will receive F/TDF, once daily up to approximately 52 weeks. Participants will also receive PTM LEN injection, every 26 weeks starting on Day 1 up to approximately 52 weeks. Participants will receive PTM LEN tablet, once daily on Day 1 and Day 2.

Treatment:

Drug: PTM Oral LEN

Drug: F/TDF

Drug: Placebo SC LEN

LEN Open-Label Extension (OLE) Phase

Experimental group

Description:

After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase. Participants randomized to LEN will continue to receive LEN 927 mg injection, every 26 weeks until LEN becomes available or the sponsor elects to discontinue the study, whichever occurs first. Participants randomized to F/TAF or F/TDF will receive LEN 927 mg injection on OLE Day 1, Week 26, and every 26 weeks thereafter. Participants will also receive LEN 600 mg tablet on OLE Days 1 and 2.

Treatment:

Drug: Oral Lenacapavir (LEN)

Drug: Subcutaneous (SC) Lenacapavir (LEN)

Pharmacokinetic (PK) Tail Coverage Phase

Experimental group

Description:

Participants who prematurely discontinue study drug in the randomized blinded phase will transition into the PK Tail Coverage phase. Participants will receive F/TDF, once daily, for 78 weeks beginning 26 weeks after the last LEN injection.

Treatment:

Drug: F/TDF