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P1066 / Raltegravir Safety, Tolerability, PK, & Antiretroviral Activity

A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress™, MK-0518) in HIV-1 Infected Children and Adolescents

Study Status

Concluded

Locality

US & Non-US

DAIDS Number

10495

IND Number

77,787

Clinical Trials Link

Summary

P1066 is a Phase I/II, multi-center, open-label, noncomparative intensive PK study.  The study is designed to evaluate the following with respect to raltegravir use in the study population:  short-term safety and tolerability; steady state plasma concentration profiles and PK parameters; and chronic dosing safety and tolerability.  Duration of study treatment in Stage I and II will be 48 weeks; subjects will have the option to continue to receive the raltegravir for 5 years from initial exposure.  The study will enroll approximately 120 to 160 HIV-infected children and adolescents between the ages of ≥4 weeks to <19 years.

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