5,368
Participants
Start Date
August 30, 2021
Primary Completion Date
May 27, 2024
Study Completion Date
January 31, 2028
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
Setshaba Research Centre, Gauteng
The Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg
The Aurum Institute: Tembisa Clinical Research Centre, Tembisa
Perinatal HIV Research Unit (PHRU) Soweto Kliptown, Kliptown
Wits Reproductive Health & HIV Institute (Wits RHI), Johannesburg
Madibeng Centre for Research, Brits
The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre, Klerksdorp
Qhakaza Mbokodo Research Clinic, Ladysmith
Botha's Hill Clinical Research Site, HIV Prevention Research Unit, Durban
Africa Health Research Institute, Mtubatuba
CAPRISA eThekwini Clinical Research Site, Durban
CAPRISA Vulindlela Clinical Research Site, Durban
MatCH Research Unit, Suite 1112, 11th Floor, Durban
Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit, Kwa Zulu Natal
CAPRISA Umlazi Clinical Research Site, Umlazi
Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit, Kwa Zulu Natal
Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit, Kwa Zulu Natal
FPD-DTHF Ndevana Community Research Site, Vincent
Desmond Tutu Health Foundation - Masiphumelele Research Office, Sunnydale
Emavundleni Research Centre, Cape Town
Vuka Research Clinic, Cape Town
Desmond Tutu Health Foundation Clinical Trials Unit, Cape Town
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
The Aurum Institute: Pretoria Clinical Research Centre, Pretoria
Lead Sponsor
Gilead Sciences
INDUSTRY