Last updated on July 2019

Pharmacokinetics Safety and Efficacy of Cobicistat-boosted Atazanavir or Cobicistat-boosted Darunavir in HIV-1 Infected Treatment-Experienced Virologically Suppressed Pediatric Subjects


Brief description of study

The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced, virologically suppressed, pediatric participants between the ages of 3 months to < 18 years of age.

This study will also evaluate the safety, tolerability, and efficacy of ATV/co or DRV/co each co-administered with a background regimen (BR) through 48 weeks and during the 5 year long-term treatment.

There will be 2 parts to the study.

  • Part A: Participants will be enrolled sequentially by age cohort to evaluate the steady state PK and confirm dose of ATV/co and DRV/co. Following screening, enrolled participants will continue their suppressive regimen of either ATV/r or DRV/r once-daily plus their BR. On Day 1, participants will discontinue ritonavir and initiate once daily cobicistat (COBI) to be taken with their ATV or DRV plus their BR. All participants enrolled in Part A will participate in an intensive PK evaluation of COBI and ATV or DRV on Day 10. Following completion of the intensive PK visit, participants will continue to receive COBI coadministered with DRV or ATV each with a BR and return for scheduled study visits.
  • Part B: Participants will be enrolled to evaluate the safety, tolerability, and efficacy of the ATV/co or DRV/co regimen. For all cohorts in Part B, participants will be screened and initiated sequentially by each age cohort following confirmation of appropriate COBI exposure and PI exposures from the corresponding age cohort in Part A.

Clinical Study Identifier: NCT02016924

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Fundacion Huesped

Buenos Aires, Argentina
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KIDCRU

Cape Town, South Africa
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Vx Pharma

Pretoria, South Africa
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University of the Free State

Bloemfontein, South Africa
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Recruitment Status: Open


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