Long-Acting Treatment in Adolescents (LATA)

Summary

The LATA trial will find out if taking a long-acting injectable form of HIV medicines, called cabotegravir and rilpivirine, every 2 month works as well as taking tablet HIV medicines every day in young people aged 12-19 years of age.

The trial is organised by an international group of researchers from Europe and Africa, and will include 460 young people, from Kenya, South Africa, Uganda and Zimbabwe.

Conditions

• Hiv
• HIV Infections
• HIV-1-infection
• Paediatric 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

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Janssen-Cilag Ltd.

  collaborator INDUSTRY

• ViiV Healthcare

  collaborator INDUSTRY

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

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• MRC/UVRI and LSHTM Uganda Research Unit

  collaborator OTHER

• Africa Health Research Institute

  collaborator OTHER

• PENTA Foundation

  collaborator NETWORK

• University of York

  collaborator OTHER

• University College, London

  lead OTHER

Principal Investigators

• Sarah L Pett · MRC CTU at University College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-22

Primary Completion

2025-03-31

Completion

2026-03-31

Countries

• Kenya
• South Africa
• Uganda
• Zimbabwe

Study Locations