Long-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
Primary Sponsor Details
Medical Research Council (MRC) Clinical Trials Unit (CTU) at University College London (UCL)
Secondary Sponsor Details
Dr. Mutsawashe Filda Bwakura-Dangarembizi
Principal Investigator
mbwakura@uz-ctrc.org
0242-701717/701356/705995 / 072 601 735
P.O. Box A1578, Avondale, Harare
UZCRC
Dr. Mutsawashe Filda Bwakura-Dangarembizi
Principal Investigator
mbwakura@uz-ctrc.org
0242-701717/701356/705995 / 072 601 735
P.O. Box A1578, Avondale, Harare
UZCRC
Zimbabwe
Kenya
South Africa
Uganda
Funded
Long-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.
1. Dolutegravir with Tenofovir and Lamivudine or Emtricitabine 2. Oral Cabotegravir. Oral Rilpivirine. Cabotegravir injection. Rilpivirine Injection.
1500
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
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
11. Contraindication to receiving injectable agents in the buttock area
12. Underlying medical condition (e.g. bleeding disorder; use of warfarin) that in the opinion of
the investigator precludes participation
13. Previous randomisation in the BREATHER Plus trial
14. Known majora resistance to non-nucleoside reverse transcriptase inhibitors or integrase
inhibitors
The proportion of participants with confirmed virological rebound, defined as the first of 2 consecutive
plasma HIV-RNA ≥50 copies/mL at any time up to the -week assessment.