P1071 (DAIDS ID 10634): 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 Study Restriction



What is P1071?

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.

Study Documents:

Sites where the study was implemented:

CRS ID Site Name City Country


Rush University Cook County Hospital Chicago NICHD CRS


United States of America

Study contacts:

CTS: IMPAACT Operations Center


Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.