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

NCT04994509

Active Not RecruitingPhase 3

Sponsor: Gilead Sciences

Conditions: Pre-Exposure Prophylaxis of HIV Infection

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

Countries: South Africa, Uganda

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.

Eligibility overview

Sex: FEMALE

Age: 16 Years to 25 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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.
Locations (28)
  • Brits, South Africa
  • Cape Town, South Africa
  • Cape Town, South Africa
  • Cape Town, South Africa
  • Durban, South Africa
  • Durban, South Africa
  • Durban, South Africa
  • Durban, South Africa
  • East London, South Africa
  • Gauteng, South Africa
  • Johannesburg, South Africa
  • Klerksdorp, South Africa
  • Kliptown, South Africa
  • Kwa Zulu Natal, South Africa
  • Kwa Zulu Natal, South Africa
  • Kwa Zulu Natal, South Africa
  • Kwa Zulu Natal, South Africa
  • Ladysmith, South Africa
  • Mtubatuba, South Africa
  • Pretoria, South Africa
  • Rustenburg, South Africa
  • Sunnydale, South Africa
  • Tembisa, South Africa
  • Umlazi, South Africa
  • Vincent, South Africa
  • Kalangala, Uganda
  • Kyotera- Masaka Region, Uganda
  • Mityana Town, Uganda