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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

Locality

Non-US

DAIDS Number

10634

IND Number

69,661

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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