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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

5,368

Participants

Timeline

Start Date

August 30, 2021

Primary Completion Date

May 27, 2024

Study Completion Date

January 31, 2028

Conditions
Pre-Exposure Prophylaxis of HIV Infection
Interventions
DRUG

Oral Lenacapavir (LEN)

Tablets administered orally without regard to food

DRUG

Subcutaneous (SC) Lenacapavir (LEN)

Administered via SC injections

DRUG

F/TAF

Tablets administered orally

DRUG

F/TDF

Tablets administered orally

DRUG

Placebo SC LEN

Administered via SC injections

DRUG

PTM Oral LEN

Tablets administered orally

DRUG

PTM F/TAF

Tablets administered orally

DRUG

PTM F/TDF

Tablets administered orally

Trial Locations (28)

152

Setshaba Research Centre, Gauteng

299

The Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg

1632

The Aurum Institute: Tembisa Clinical Research Centre, Tembisa

1809

Perinatal HIV Research Unit (PHRU) Soweto Kliptown, Kliptown

2038

Wits Reproductive Health & HIV Institute (Wits RHI), Johannesburg

2500

Madibeng Centre for Research, Brits

2571

The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre, Klerksdorp

3370

Qhakaza Mbokodo Research Clinic, Ladysmith

3660

Botha's Hill Clinical Research Site, HIV Prevention Research Unit, Durban

3935

Africa Health Research Institute, Mtubatuba

4001

CAPRISA eThekwini Clinical Research Site, Durban

CAPRISA Vulindlela Clinical Research Site, Durban

MatCH Research Unit, Suite 1112, 11th Floor, Durban

4061

Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit, Kwa Zulu Natal

4066

CAPRISA Umlazi Clinical Research Site, Umlazi

4340

Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit, Kwa Zulu Natal

4400

Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit, Kwa Zulu Natal

5217

FPD-DTHF Ndevana Community Research Site, Vincent

7705

Desmond Tutu Health Foundation - Masiphumelele Research Office, Sunnydale

7750

Emavundleni Research Centre, Cape Town

7784

Vuka Research Clinic, Cape Town

7925

Desmond Tutu Health Foundation Clinical Trials Unit, Cape Town

Unknown

Synergy Biomed Research Institute (SBRI), East London

Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit, Kwa Zulu Natal

Makerere-Kalangala Clinical Research site, Kalangala

AMBSO Masaka Clinical Research site, Kyotera- Masaka Region

Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd, Mityana Town

0087

The Aurum Institute: Pretoria Clinical Research Centre, Pretoria

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY