Long-Acting Treatment in Adolescents (LATA) (NCT05154747) | Clinical Trial Compass
UnknownPhase 3
Long-Acting Treatment in Adolescents (LATA)
Kenya, South Africa, Uganda476 participantsStarted 2023-06-22
Plain-language 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.
Who can participate
Age range12 Years â 19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
â. HIV-1-infected
â. Aged 12-19 years
â. Aware of HIV status
â. Body weight âĽ35Kg
â. On ART consisting of 2NRTI and a third agent
â. On ART for âĽ1 year with no previous regimen change for treatment failure\*
â. Virologically suppressed with all HIV-1 RNA viral loads \<50copies/mLÂĽ in the last 12 months up to and including screening. Additionally, there must be one result \<50copies/mL at least 12 months prior to screening and the viral load at trial screening must be \<50 copies/mL
â. Written informed consent provided by participant (if aged 18 to 19 years) and/or carer/legal guardian (if participant aged 12 to 17 years) as appropriate
Exclusion criteria
â. Known HIV-2 infection
â. Females who are pregnant or breastfeeding
â. Females who plan to become pregnant during the trial follow-up or are sexually active and are unwilling to avoid pregnancy for the duration of the trial
â. Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale