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STATUS Recruitment Complete

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

LAST UPDATED

February 24 2025

Clinicaltrials.gov ID

NCT04994509

OVERVIEW

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 (PURPOSE 1)

PROTOCOL SUMMARY

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.

Participation Requirements

Calendar

Age

16 Years - 25 Years

Condition

Sex

FEMALE

Healthy Icon

Healthy Volunteers

true

Study Details

Medical Condition

Pre-Exposure Prophylaxis of HIV Infection

Gender

Cisgender Female

Date

August 2021 - May 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF, F/TDF, Placebo SC LEN, PTM Oral LEN, PTM F/TAF, PTM F/TDF

Eligibility Information

Inclusion

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.
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Exclusion

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.

Locations

Locations (28)
Other

Madibeng Centre for Research

Brits, South Africa, 2500

Other

Emavundleni Research Centre

Cape Town, South Africa, 7750

Other

Vuka Research Clinic

Cape Town, South Africa, 7784

Other

Desmond Tutu Health Foundation Clinical Trials Unit

Cape Town, South Africa, 7925

Other

Botha's Hill Clinical Research Site, HIV Prevention Research Unit

Durban, South Africa, 3660

Other

CAPRISA eThekwini Clinical Research Site

Durban, South Africa, 4001

Other

CAPRISA Vulindlela Clinical Research Site

Durban, South Africa, 4001

Other

MatCH Research Unit, Suite 1112, 11th Floor

Durban, South Africa, 4001

Other

Synergy Biomed Research Institute (SBRI)

East London, South Africa

Other

Setshaba Research Centre

Gauteng, South Africa, 152

Other

Wits Reproductive Health & HIV Institute (Wits RHI)

Johannesburg, South Africa, 2038

Other

The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre

Klerksdorp, South Africa, 2571

Other

Perinatal HIV Research Unit (PHRU) Soweto Kliptown

Kliptown, South Africa, 1809

Other

Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

Kwa Zulu Natal, South Africa, 4061

Other

Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

Kwa Zulu Natal, South Africa, 4340

Other

Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

Kwa Zulu Natal, South Africa, 4400

Other

Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

Kwa Zulu Natal, South Africa

Other

Qhakaza Mbokodo Research Clinic

Ladysmith, South Africa, 3370

Other

Africa Health Research Institute

Mtubatuba, South Africa, 3935

Other

The Aurum Institute: Pretoria Clinical Research Centre

Pretoria, South Africa, 0087

Other

The Aurum Institute: Rustenburg Clinical Research Centre

Rustenburg, South Africa, 299

Other

Desmond Tutu Health Foundation - Masiphumelele Research Office

Sunnydale, South Africa, 7705

Other

The Aurum Institute: Tembisa Clinical Research Centre

Tembisa, South Africa, 1632

Other

CAPRISA Umlazi Clinical Research Site

Umlazi, South Africa, 4066

Other

FPD-DTHF Ndevana Community Research Site

Vincent, South Africa, 5217

Other

Makerere-Kalangala Clinical Research site

Kalangala, Uganda

Other

AMBSO Masaka Clinical Research site

Kyotera- Masaka Region, Uganda

Other

Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd

Mityana Town, Uganda