DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children with HIV Infection Aged 2 to <15 Years Old

Inclusion Criteria:

1. HIV-1 infected children who are virologically suppressed for at least the last 6months prior to enrolment

2. Aged 2 to <15 years old

3. Weight 6 kg or higher

4. Children on the same triple-drug PI/r, NNRTI or INSTI containing ART regimen for atleast 3 months

5. Girls who have reached menarche must have a negative pregnancy test at screening andrandomisation

6. Girls who are sexually active must be willing to adhere to highly effective methodsof contraception

7. A parent or legal guardian is willing and able to give informed consent on behalf ofthe child as per national legislation and willing to adhere to the protocol

8. Participant is willing to give informed assent if the trial site clinician deemsthem old enough and able to understand the age-appropriate information aboutparticipation in the study

Exclusion Criteria:

1. Any previous switch in ART regimen for virological, immunological or clinicaltreatment failure

2. Any changes in ART in the last 6 months for reasons other than due to child'sgrowth, drug stock-outs, changes in country guidelines and treatment simplification

3. Evidence of previous resistance to 3TC or INSTI

4. Any prior use of regimens consisting of single or dual NRTIs with the exception of acourse of zidovudine for PMTCT

5. Known allergy or contraindications to dolutegravir or lamivudine

6. Diagnosis of tuberculosis and on anti-tuberculosis treatment; children can beenrolled after successful tuberculosis treatment

7. Treatment of co-morbidities with drugs which have significant interactions withantiretroviral treatment, requiring dose adjustment of the study drugs (children canbe enrolled after the illness resolves)

8. Randomisation visit more than 12 weeks after the most recent screening visit

9. Evidence of hepatitis B infection with no protective immunity against hepatitis B:participants positive for HBsAg or HBcAb and negative for HBsAb

10. Anticipated need for hepatitis C virus therapy with interferon-based regimen priorto the primary endpoint.

11. Screening ALT equal to 3 or more times the upper limit of normal AND bilirubin equalto 2 or more times the upper limit of normal (ALT ≥3xULN AND bilirubin ≥2xULN)

12. Screening ALT equal to 5 or more times the upper limit of normal ALT (≥5xULN)

13. Patients with severe hepatic impairment or unstable liver disease (as defined by thepresence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal orgastric varices, or persistent jaundice), or known biliary abnormalities (with theexception of Gilbert's syndrome or asymptomatic gallstones)

14. Screening creatinine clearance <50 mL/min/1.73m2

15. Patients aged ≥6 years at moderate or high risk of suicide as determined byColumbia-Suicide Severity Rating Scale (C-SSRS)

16. Girls who are pregnant or breastfeeding

17. Children who are in the legal custody of the State and do not have a parent orguardian able to provide informed consent on their behalf.