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 range
12 Years – 19 Years
Sex
ALL
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
. HIV-1-infected
. Aged 12-19 years
. Aware of HIV status
. Body weight ≥35Kg
. On ART consisting of 2NRTI and a third agent
. On ART for ≥1 year with no previous regimen change for treatment failure\*
. Virologically suppressed with all HIV-1 RNA viral loads \<50copies/mL¥ 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Known HIV-2 infection
. Females who are pregnant or breastfeeding
. 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
. Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale
. Hepatitis B SAg positive
. ALT ≥3 x upper limit of normal
. On treatment for active TB
. Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir