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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Raltegravir | Other / unclassified | 300 mg | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |