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)
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.
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Age
16 Years - 25 Years
Sex
Female
Healthy Volunteers
Accepts Healthy Volunteers
Medical Condition
Pre-Exposure Prophylaxis of HIV Infection
Gender
Cisgender Female
Date
August 2021 - September 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
Brits, South Africa, 2500
Cape Town, South Africa, 7750
Cape Town, South Africa, 7784
Cape Town, South Africa, 7925
Durban, South Africa, 3660
Durban, South Africa, 4001
Durban, South Africa, 4001
Durban, South Africa, 4001
East London, South Africa
Gauteng, South Africa, 152
Johannesburg, South Africa, 2038
Klerksdorp, South Africa, 2571
Kliptown, South Africa, 1809
Kwa Zulu Natal, South Africa, 4061
Kwa Zulu Natal, South Africa, 4340
Kwa Zulu Natal, South Africa, 4400
Kwa Zulu Natal, South Africa
Ladysmith, South Africa, 3370
Mtubatuba, South Africa, 3935
Pretoria, South Africa, 0087
Rustenburg, South Africa, 299
Sunnydale, South Africa, 7705
Tembisa, South Africa, 1632
Umlazi, South Africa, 4066
Vincent, South Africa, 5217
Kalangala, Uganda
Kyotera- Masaka Region, Uganda
Mityana Town, Uganda
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