SMILE: Strategy for Maintenance of HIV suppression with elvitegravir+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 elvitegravir (EVG) administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants. - PENTA 17 - SMILE

Fondazione PENTA ONLUS0 个研究点目标入组 300 人开始时间: 2016年7月13日最近更新: 2020年3月11日

研究概览

暂无简介。

•1.HIV-1 infected children weighting > 17 kg 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 elvitegravir + darunavir/ritonavir arm
•7.Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met
•8.For children aged 6-12 either:
•-children and caregivers are willing to participate in the lead-in PK study if the child is aged 6-12 and the PK study (for children randomised to Arm 1) is still enrolling children in their weight band OR
•- Data from the lead-in PK study have been analysed and children aged 6-12 can be enrolled directly into the main study
•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

•1.Receiving or requiring agents with interactions with darunavir, RTV, or EVG
•2.Evidence of resistance to DRV or integrase inhibitors
•3.Previous exposure to integrase inhibitors for more than 2 weeks
•4.History of previous encephalopathy
•5.Intercurrent illness
•6.Creatinine, AST or ALT of grade 3 or above at screening.
•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.

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