476
Participants
Start Date
June 22, 2023
Primary Completion Date
March 31, 2025
Study Completion Date
March 31, 2026
Cabotegravir, Rilpivirine Drug Combination
"Cabotegravir LA 600mg as a 3mL IM injection. The product is packaged in a 3mL USP Type I glass vial. Each vial is for single-dose use. CAB LA injectable suspension is to be stored according to the product label at room temperature (\<30oC). CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol3350, mannitol, and water for injection.~Rilpivirine LA 900mg as a 3mL IM injection. Each single-dose vial contains 900mg/3mL rilpivirine. RPV LA injectable suspension should be stored according to the product label refrigerated at 2-8oC and should be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, and water for injection.~Cabotegravir Long-Acting (CAB LA) will be given IM into one buttock, and Rilpivirine Long-Acting (RPV LA) will be given IM into the opposite buttock."
TLD
Dolutegravir 50mg oral with tenofovir disoproxil fumarate (245mg) and lamivudine (300mg) in a fixed dose combination or Dolutegravir 50mg oral with tenofovir alafenamide fumarate (25mg) and lamivudine (300mg) (l/TAF) oral in a fixed dose combination
Moi University, Eldoret
Enhancing Care Foundation King Edward VIII Hospital, Durban
Baylor College of Medicine Childrens Foundation Uganda, Kampala
Joint Clinical Research Centre, Kampala
University of Zimbabwe Clinical Research Centre, Harare
Collaborators (2)
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Janssen-Cilag Ltd.
INDUSTRY
ViiV Healthcare
INDUSTRY
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.
OTHER
London School of Hygiene and Tropical Medicine
OTHER
MRC/UVRI and LSHTM Uganda Research Unit
OTHER
Africa Health Research Institute
OTHER
PENTA Foundation
NETWORK
University of York
OTHER
University College, London
OTHER