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P1058A / Pharmacokinetics of New Classes of Antiretroviral Drug Combinations

Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents, and Young Adults

Study Status

Concluded

DAIDS Number

10809

IND Number

Non-IND

Primary Protocol Team Members

Stephen Spector Consultant
Donna Picard Field Representative
Siham Akleh Field Representative
Chintana Khamrong Field Representative
Samantha (Tamara) Kuryla ICAB Representative
Douglas Watson Investigator
Marc Foca Investigator
Anthony Ogwu Investigator
Mary Paul Investigator
Alexander Benns Laboratory Data Manager (LDM)
Linda Lambrecht Laboratory Technologist
Robin DiFrancesco Laboratory Technologist
Patrick Jean-Philippe Medical Officer
Kajal Larson Pharmacologist
Vincent Carey Statistician
Paula Britto Statistician
Scott Watson Westat Representative
Andrew Wiznia Study Vice-Chair
Linda Barlow-Mosha Study Vice-Chair
Cristina Hofer Study Vice-Chair

Summary

P1058a is a pharmacokinetic study of new classes of antiretroviral (ARV) drug combinations in children, adolescents, and young adults (6-23 years of age).  The study is designed to evaluate the 12- and/or 24-hour pharmacokinetics of up to 17 ARV drug combinations in approximately 200 participants in the US (15-40 participants per drug combination).

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