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P1101

Phase I/II Dose-Finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected Infants and Children

Study Status

Participants Off Study and Primary Analysis Completed

DAIDS Number

11831

IND Number

77,787

Clinical Trials Link

Summary

P1101 is a Phase I/II, dose-finding, safety, tolerability, drug-drug interaction and pharmacokinetics study of Raltegravir (RAL) in TB co-infected children (≥ 4 weeks to < 12 years of age) taking Rifampicin (RIF)-based tuberculosis (TB) therapy. The study objectives are to determine the pharmacokinetics and appropriate dose of RAL and to determine safety and tolerance of RAL-containing ART when administered with a RIF-containing anti-TB therapy in HIV/TB co-infected children.

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