HIV/AIDS
Conditions
Interventions
Combination ART
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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/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 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 *VL <100 copies/mL is allowed for diluted samples with maximum dilution 1:5, except for the screening sample where the VL must be <50 copies/mL in an undiluted sample **Highly effective contraception are injectable, implantable, oral and intrauterine contraceptives which have an expected failure rate <1% per year
Exclusion criteria
Exclusion criteria: 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 **Highly effective contraception are injectable, implantable, oral and intrauterine contraceptives which have an expected failure rate <1% per year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) Proportion of participants with confirmed HIV-RNA =50 copies/mL at 48 and 96 weeks using the modified FDA snapshot algorithm ;(ii) The proportion of participants with confirmed HIV-RNA =1000 copies/mL defined as 2 consecutive plasma HIV-RNA =1000 copies/mL at any time up to the 96-week assessment ;(iii) The number/type of HIV mutations at confirmed HIV-1 RNA =50copies/mL ;(iv) The proportion of participants with HIV-RNA <50 copies/mL and no switch to second-line ART for treatment failure at 24, 48, 64 and 96 weeks;(i) Change in toxicity profile including change in metabolic parameters (lipids, HbA1c, phosphate), renal function (eGFR) from baseline to 96 weeks; change in anthropometric measures from baseline to 48 and 96 weeks ;(ii) Time to any new or recurrent WHO 3 or WHO 4 event or death ;(iii) Incidence of serious, grade 3-4 and treatment-modifying grade 1-2 adverse events ;(iv) The proportion of participants with any change from baseline ART regimen ;(v) Change in CD4+ and CD8+ T-cell count from baseline to 48 and 96 weeks;(i) Adherence, acceptability, wellbeing and including neuropsychiatric problems (e.g. depression, anxiety and sleep disturbance) ;(ii) Healthcare resource utilisation (a sub-study outcome) ;(iii) Health-related quality-of-life (a sub-study outcome) | — |
Countries
Kenya, South Africa, Uganda, Zimbabwe
Contacts
Public ContactHelen Ainscough
Trial Manager
Outcome results
None listed