Last updated on October 2017

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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Jagmohan Batra, MD

Pediatric Infectious Diseases Associate
Long Beach, CA United States
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Gilead Study Team

Children's Hospital Los Angeles
Los Angeles, CA United States
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Gilead Study Team

University of Southern California
Los Angeles, CA United States
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Elizabeth McFarland, MD

Children's Hospital Colorado
Aurora, CO United States
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Natella Rakhmanina

Children's National Medical Center
Washington, D.C., United States
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Carina Rodriguez, MD

University of South Florida Clinic at Children's Medical Services
Tampa, FL United States
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Rana Chakraborty, MD

Grady Health System
Atlanta, GA United States
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Gilead Study Team

Boston Medical Center
Boston, MA United States
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William Borkowsky, MD

Bellevue Hospital
New York, NY United States
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Leonard Weiner, MD

SUNY Upstate Medical University
Syracuse, NY United States
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Aditya Gaur, MD

St. Jude Children's Research Hospital
Memphis, TN United States
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Gloria Heresi, MD

University of Texas Health Science Center of Houston
Houston, TX United States
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Diego Cecchini

Hospital General de Agudos Dr. Cosme Argerich
Buenos Aires, Argentina
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Maria R Bologna

Helios Salud S.A.
Buenos Aires, Argentina
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Erica Stankievich

Hospital Ramos Mej a
Buenos Aires, Argentina
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Pedro Cahn

Fundacion Huesped
Buenos Aires, Argentina
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Wicharn Luesomboon

Queen Savang Vadhana Memorial Hospital
Sriracha, Thailand
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Pope Kosalaraksa

Srinagarind Hospital Khon Kaen University
Amphur Muang, Thailand
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Kulkanya Chokephaibulkit

Siriraj Hospital Mahidol University
Bangkok, Thailand
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Sivaporn Gatechompol

The HIV NAT Research Collaboration
Bangkok, Thailand
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