Clinical trial NCT04994509: Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pre-Exposure Prophylaxis of HIV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 5368
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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 long-acting systemic HIV pre-exposure prophylaxis (PrEP) or or HIV PEP (postexposure prophylaxis).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY)
timeFrame: At Screening
measure: Randomized Phase: HIV Incidence Reported Per 100-PY of Follow-up
timeFrame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
Secondary outcomes:
measure: HIV Incidence Among Participants While Adherent to Study Drug
timeFrame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
measure: Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
timeFrame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
Other outcomes:
Locations:
city: Brits
country: South Africa
facility: Madibeng Centre for Research
city: Cape Town
country: South Africa
facility: Emavundleni Research Centre
city: Cape Town
country: South Africa
facility: Vuka Research Clinic
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation Clinical Trials Unit
city: Durban
country: South Africa
facility: Botha's Hill Clinical Research Site, HIV Prevention Research Unit
city: Durban
country: South Africa
facility: CAPRISA eThekwini Clinical Research Site
city: Durban
country: South Africa
facility: CAPRISA Vulindlela Clinical Research Site
city: Durban
country: South Africa
facility: MatCH Research Unit, Suite 1112, 11th Floor
city: East London
country: South Africa
facility: Synergy Biomed Research Institute (SBRI)
city: Gauteng
country: South Africa
facility: Setshaba Research Centre
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health & HIV Institute (Wits RHI)
city: Klerksdorp
country: South Africa
facility: The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre
city: Kliptown
country: South Africa
facility: Perinatal HIV Research Unit (PHRU) Soweto Kliptown
city: Kwa Zulu Natal
country: South Africa
facility: Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
city: Kwa Zulu Natal
country: South Africa
facility: Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
city: Kwa Zulu Natal
country: South Africa
facility: Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
city: Kwa Zulu Natal
country: South Africa
facility: Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
city: Ladysmith
country: South Africa
facility: Qhakaza Mbokodo Research Clinic
city: Mtubatuba
country: South Africa
facility: Africa Health Research Institute
city: Pretoria
country: South Africa
facility: The Aurum Institute: Pretoria Clinical Research Centre
city: Rustenburg
country: South Africa
facility: The Aurum Institute: Rustenburg Clinical Research Centre
city: Sunnydale
country: South Africa
facility: Desmond Tutu Health Foundation - Masiphumelele Research Office
city: Tembisa
country: South Africa
facility: The Aurum Institute: Tembisa Clinical Research Centre
city: Umlazi
country: South Africa
facility: CAPRISA Umlazi Clinical Research Site
city: Vincent
country: South Africa
facility: FPD-DTHF Ndevana Community Research Site
city: Kalangala
country: Uganda
facility: Makerere-Kalangala Clinical Research site
city: Kyotera- Masaka Region
country: Uganda
facility: AMBSO Masaka Clinical Research site
city: Mityana Town
country: Uganda
facility: Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: