SMILE: Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor+darunavir/ritonavir in childrEn (PENTA 17).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 318

Inclusion Criteria

1.HIV-1 infected children aged =12 years old and weighting = 40kg* at the screening visit
2.Aged 6 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 INSTI + darunavir/ritonavir arm
7.Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met
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.
**. As more data become available on younger children, a protocol amendment is planned to include younger children and/or lower weight bands.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Receiving or requiring agents with interactions with DRV, RTV, or any once daily integrase inhibitor
2.Evidence of resistance to DRV or integrase inhibitors
3.Previous exposure to integrase inhibitors for more than 2 weeks
4.Intercurrent illness
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 known biliary abnormalities
7.Diagnosis of tuberculosis and on anti-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether children with chronic HIV infection on ART with suppressed viral load will maintain similar levels of suppression with once daily integrase inhibitor+ darunavir/r (INSTI+DRV/r) compared to current standard of care triple ART.;Secondary Objective: - To evaluate the impact on clinical progression, inmmunovirological parameters, mitochondrial toxicity, lipid profile, bone mineral density, adherence, acceptability and quality of life of the Dual combination of INSTI+DRV/r compared to current standard of care triple ART.<br>- To evaluate INSTI+DRV/r drug exposure and drug-drug interactions.;Primary end point(s): Percentage of patients with HIV-1 RNA = 50 c/mL (confirmed within 4 weeks) ;Timepoint(s) of evaluation of this end point: Any time up to week 48

Secondary Outcome Measures

Name	Time	Method

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