SMILE: Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor+darunavir/ritonavir in childrEn (PENTA 17) - A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants. - PENTA 17 - SMILE

Fondazione PENTA ONLUS0 sites318 target enrollmentDecember 11, 2015

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2015

End Date

November 17, 2021

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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.

•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