Study of AVT/co DRV/co in virologically suppressed paediatric subjects

• Research type

  Research Study

• Full title

  A Phase 2/3, Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co), Administered with a Background Regimen (BR) in HIV-1 Infected, Treatment-Experienced, Virologically Supressed Pediatric Subjects.

• IRAS ID

  237346

• Contact name

  Caroline Foster

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2013-001402-28

• Duration of Study in the UK

  6 years, 9 months, 1 days

• Research summary

  HIV-1 infection is a life-threatening and serious disease that is of major public health interest. There are approximately 34 million people living with HIV-1 worldwide (Campsmith et al 2010, WHO 2011). The infection, if left untreated or not effectively treated, reduces the immune defence function, the subsequent occurrence of opportunistic infections and cancer, ultimately resulting in death. Infants and children infected with HIV-1 tend to progress more rapidly than adults. Treatment methods for HIV-1 disease in adults and children have been improved by the availability of highly active antiretroviral therapy.
  This study will assess the efficacy and safety of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) in children and adolescents who are antiretroviral treatment-experienced, virologically suppressed. Cobicistat is a drug that does not have anti-HIV activity when taken alone. It functions as a “booster” drug when it is taken with protease inhibitors, such as Darunavir or Atazanavir stay in the body longer. Up to 100 patients, from university sites and second care unit hospitals, will take part in this study which will consist of 3 phases: screening, treatment and follow-up. Total duration on trial for the patient for treatment is 48 weeks plus an additional 5-year long-term phase. Participants for this study will be aged 3 months to < 18 years of age.
  This is an open-label, non-randomised study and Gilead Sciences, Inc. is the sponsor.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  18/LO/0518

• Date of REC Opinion

  25 Jul 2018

• REC opinion

  Further Information Favourable Opinion