PACTR202302484199604
Not yet recruiting
Phase 3
ong-Acting Treatment in Adolescents (LATA): A randomised open-label 2-arm 96 week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa
niversity College London0 sites460 target enrollmentJanuary 19, 2023
ConditionsHIV/AIDS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- niversity College London
- Enrollment
- 460
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.HIV\-1\-positive
- •2\.Aged 12\-19 years
- •3\.Aware of HIV status
- •4\.Body weight \=35Kg
- •5\.On ART consisting of 2NRTI and a third agent
- •6\.On ART for \=1 year with no previous regimen change for treatment failure\*
- •7\.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
- •8\.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
- •9\.Written informed assent in participants aged 12 to 17 years
- •10\.Females who are sexually active must be willing to adhere to highly effective methods of contraception¦
Exclusion Criteria
- •1\.Known HIV\-2 positive
- •2\.Females who are pregnant or breastfeeding
- •3\.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
- •4\.Moderate or high\-risk score on the Columbia\-Suicide Severity Rating Scale
- •5\.Hepatitis B SAg positive
- •6\.ALT \=3 x upper limit of normal
- •7\.On treatment for active TB
- •8\.Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir
- •9\.Participants determined by the investigator to have a high risk of seizure, including those with unstable or poorly controlled seizure disorder
- •10\.Unwilling or contraindication to receiving injections
Outcomes
Primary Outcomes
Not specified
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