drugset / Trial / NCT01717287

A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)

NCT01717287

Phase 2 Completed 32 enrolled Merck Sharp & Dohme LLC Covance · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1). As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use of raltegravir in the pediatric HIV-infected population in Russia.

Timeline

Start
2012-11-16
Primary completion
2013-12-11
Completion
2013-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Raltegravir Other / unclassified 300 mg Oral
Subject Raltegravir Other / unclassified 400 mg Oral