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P1071 / CCR5 Vicriviroc (SCH-417690)
Phase I/II Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Vicriviroc (SCH-417690) a novel CCR5 Antagonist in combination regimens in Antiretroviral Therapy Experienced Children and Adolescents
Study Status
Concluded
DAIDS Number
10634
IND Number
69,661
Primary Protocol Team Members
Summary
P1071 was a Phase I/II, multi-center, open-label, two stage, age-stratified, intensive PK non-comparative study of Vicriviroc. The study was designed to evaluate the short and long term safety and tolerability as well as the multidose pharmacokinetics of the drug in combination with optimized background therapy among HIV-infected, treatment-experienced children and adolescent.
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