SMILE: Strategy for Maintenance of HIV suppression with once daiLyIntegrase inhibitor+darunavir/ritonavir in children (PENTA 17) -A two-arm, Phase 2/3 multicentre, open-label, randomised studyevaluating safety and antiviral effect of current standard antiretroviraltherapy compared to once daily integrase inhibitor administered withdarunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressedpaediatric participants. - SMILE (PENTA 17)

PENTA Foundation0 sites300 target enrollmentMarch 17, 2016

Overview

No summary available.

Registry

who.int

Start Date

March 17, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

PENTA Foundation

•1\.HIV\-1 infected children aged \= 12 years old and weighing \=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 6 months.
•6\.Children/parents/guardians prepared to switch if randomised to once daily integrase inhibitor \+ darunavir/ritonavir arm
•7\.Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met
•\* 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.
•Are the trial subjects under 18? yes

•1\.Receiving or requiring agents with interactions with darunavir, RTV, or once daily intergrase inhibitors
•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