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Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
Sponsor: Gilead Sciences
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
16 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
5368
Start Date
2021-08-30
Completion Date
2028-01
Last Updated
2026-03-30
Healthy Volunteers
Yes
Interventions
Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Subcutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
F/TAF
Tablets administered orally
F/TDF
Tablets administered orally
Placebo SC LEN
Administered via SC injections
PTM Oral LEN
Tablets administered orally
PTM F/TAF
Tablets administered orally
PTM F/TDF
Tablets administered orally
Locations (28)
Madibeng Centre for Research
Brits, South Africa
Emavundleni Research Centre
Cape Town, South Africa
Vuka Research Clinic
Cape Town, South Africa
Desmond Tutu Health Foundation Clinical Trials Unit
Cape Town, South Africa
Botha's Hill Clinical Research Site, HIV Prevention Research Unit
Durban, South Africa
CAPRISA eThekwini Clinical Research Site
Durban, South Africa
CAPRISA Vulindlela Clinical Research Site
Durban, South Africa
MatCH Research Unit, Suite 1112, 11th Floor
Durban, South Africa
Synergy Biomed Research Institute (SBRI)
East London, South Africa
Setshaba Research Centre
Gauteng, South Africa
Wits Reproductive Health & HIV Institute (Wits RHI)
Johannesburg, South Africa
The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre
Klerksdorp, South Africa
Perinatal HIV Research Unit (PHRU) Soweto Kliptown
Kliptown, South Africa
Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa
Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa
Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa
Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, South Africa
Qhakaza Mbokodo Research Clinic
Ladysmith, South Africa
Africa Health Research Institute
Mtubatuba, South Africa
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, South Africa
The Aurum Institute: Rustenburg Clinical Research Centre
Rustenburg, South Africa
Desmond Tutu Health Foundation - Masiphumelele Research Office
Sunnydale, South Africa
The Aurum Institute: Tembisa Clinical Research Centre
Tembisa, South Africa
CAPRISA Umlazi Clinical Research Site
Umlazi, South Africa
FPD-DTHF Ndevana Community Research Site
Vincent, South Africa
Makerere-Kalangala Clinical Research site
Kalangala, Uganda
AMBSO Masaka Clinical Research site
Kyotera- Masaka Region, Uganda
Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd
Mityana Town, Uganda