BREATHER+

Primary Sponsor Details

Secondary Sponsor Details

Zimbabwe

South Africa

Uganda

Kenya

1. HIV-1-infected

2. Aged 12 to 19 years

3. Aware of HIV status

4. On ART for ≥1 year, with no previous regimen change for treatment failure

5. On ART consisting of DTG, tenofovir and lamivudine/emtricitabine for ≥1 month prior to screening

6. Virologically suppressed with all HIV-1 RNA viral loads <50copies/mLa in the last 12 months up to and including screening. Additionally, there must be one result <50copies/mLa at least 12 months prior to screening and the viral load at trial screening must be <50 copies/mL

7. Girls who are sexually active must be willing to adhere to highly effective methods of contraception

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

1. Females who are pregnant or breastfeeding

2. Females who plan to become pregnant during the trial follow-up or are unwilling to use a highly effective method of contraception for the duration of the trial if sexually active

3. Moderate or High-risk score on the Columbia-Suicide Severity Rating Scale

4. On treatment for any active TB

5. Contraindication to continued receipt of dolutegravir or any formulation of tenofovir, lamivudine/emtricitabine

6. Underlying medical condition that in the opinion of the Investigator precludes participation

7. Previous randomisation in the LATA trial

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 96-week assessment.

9.0 DESIGN OF THE TRIAL

If controlled