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 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.
View moreParticipation requirements
Age
16 years - 25 years
Sex
FEMALE
Healthy Volunteers
true
Age
16 years - 25 years
Sex
FEMALE
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
Phase 3
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 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.
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.
Locations
Locations (28)
Desmond Tutu Health Foundation Clinical Trials Unit
Cape Town, South Africa, 7925
Botha's Hill Clinical Research Site, HIV Prevention Research Unit
Durban, South Africa, 3660
MatCH Research Unit, Suite 1112, 11th Floor
Durban, South Africa, 4001
Wits Reproductive Health & HIV Institute (Wits RHI)
Johannesburg, South Africa, 2038
The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre
Klerksdorp, South Africa, 2571
Perinatal HIV Research Unit (PHRU) Soweto Kliptown
Kliptown, South Africa, 1809
Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa, 4061
Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa, 4340
Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa, 4400
Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa,
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, South Africa, 0087
The Aurum Institute: Rustenburg Clinical Research Centre
Rustenburg, South Africa, 299
Desmond Tutu Health Foundation - Masiphumelele Research Office
Sunnydale, South Africa, 7705
The Aurum Institute: Tembisa Clinical Research Centre
Tembisa, South Africa, 1632
Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd
Mityana Town, Uganda,
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