Last updated on November 2019

Study Evaluating Pharmacokinetics (PK) Safety and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Virologically Suppressed Pediatric Participants


Brief description of study

Cohort 1:

The primary objectives are:

  • To evaluate the steady-state pharmacokinetics (PK) of Atazanavir (ATV) and Darunavir (DRV) and confirm the dose of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) in HIV-1 infected, virologically suppressed adolescent participants weighing 25 kg (12 to < 18 years of age)
  • To evaluate the safety and tolerability of ATV/co or DRV/co through 24 weeks in HIV-1 infected, virologically suppressed adolescent participants weighing 25 kg (12 to < 18 years of age)

Cohort 2:

The primary objectives are:

  • To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing 25 to < 35 kg (6 to < 12 years of age)
  • To evaluate the steady-state PK of tenofovir alafenamide (TAF) and confirm the dose of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, virologically suppressed pediatric participants weighing 25 to < 35 kg (6 to < 12 years of age)
  • To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing 25 to < 35 kg (6 to < 12 years of age)

Cohort 3:

The primary objectives are:

  • To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing 14 to < 25 kg ( 3 years of age)
  • To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected, virologically suppressed pediatric participants weighing 14 to < 25 kg ( 3 years of age)
  • To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing 14 to < 25 kg ( 3 years of age)

Clinical Study Identifier: NCT02016924

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