Strategie de maintenance de la suppression virale du VIH avec dolutegravir + darunavir/ritonavir chez les enfants infectés par le VIH-1 (SMILE/PENTA17)

Drug: DTG +DRV/r;Drug: SOC

Inclusion Criteria:

1. HIV-1 infected children aged = 12 years old and weighing =40kg* at the screening visit

2. Aged 12 to < 18 years old**

3. Parents or guardians, and children where appropriate, willing and able to give
informed consent and to adhere to the protocol

4. Children must have all HIV-1 RNA viral loads <50c/mL for at least 12 months with a
minimum of two separate results before screening.

5. Children on a 3-drug PI/r or NNRTI containing regimen for at least 24 weeks

6. Children/parents/guardians prepared to switch if randomised to once daily integrase
inhibitor + DRV/RTV arm

7. Children and parents prepared to restart the current ART regimen after simplification
if viral load restart criteria are met (see Section 5.5)

8. Be affiliated or beneficiary to Health Social security scheme (in countries where this
is mandatory)

- Initially enrolment will be of participants = 12 years old and =40kg only. DTG 50
mg will be supplied by ViiV Healthcare.

- As more data become available on younger children, a protocol amendment is
planned to include younger children and/or lower weight bands.

Exclusion Criteria:

1. Receiving or requiring agents with interactions with DRV, RTV, or any once daily
integrase inhibitor (Appendix 14)

2. Evidence of resistance to DRV or integrase inhibitors (for participants in clinical
sites where resistance testing is standard of care)

3. Previous exposure to integrase inhibitors for more than 2 weeks

4. Intercurrent illness (randomisation can take place after the illness resolves)

5. Creatinine = 1.8ULN or ALT = 5ULN or ALT = 3ULN and bilirubin =2ULN at screening.

6. Patients with severe hepatic impairment or unstable liver disease (as defined by the
presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or
gastric varices, or persistent jaundice), known biliary abnormalities (with the
exception of Gilbert's syndrome or asymptomatic gallstones)

7. Diagnosis of tuberculosis and on anti-tuberculosis treatment (children can be enrolled
after successful tuberculosis treatment)

8. Hepatitis B or Hepatitis C co-infection

9. Pregnancy or risk of pregnancy in girls of child-bearing potential unless committed to
taking effective contraception

10. History or presence of known allergy or some other contraindication to the study drugs
or their components as described in the SmPC