Long-Acting Treatment in Adolescents (LATA)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

476

Participants

Timeline

Start Date

June 22, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2026

Conditions
HivHIV InfectionsHIV-1-infectionPaediatric Human Immunodeficiency Virus Infection
Interventions
DRUG

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."

DRUG

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

Trial Locations (5)

Unknown

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

All Listed Sponsors
collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

Janssen-Cilag Ltd.

INDUSTRY

collaborator

ViiV Healthcare

INDUSTRY

collaborator

Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

MRC/UVRI and LSHTM Uganda Research Unit

OTHER

collaborator

Africa Health Research Institute

OTHER

collaborator

PENTA Foundation

NETWORK

collaborator

University of York

OTHER

lead

University College, London

OTHER

NCT05154747 - Long-Acting Treatment in Adolescents (LATA) | Biotech Hunter | Biotech Hunter