CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Raltegravir Film-coated Tablet +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01717287
NCT01717287Phase 2Completed
CompareCT.gov

A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Children and Adolescents

Merck Sharp & Dohme LLC·interventional·Posted Oct 30, 2012·Updated Aug 21, 2018

In Brief

A Phase 2 clinical trial evaluating Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet, and 1 other intervention for HIV Infection. Completed, enrolled 32 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
Countries--
CollaboratorsCovance

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2012
Enrollment StartNov 16, 2012
Primary CompletionDec 11, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.7 years ago

Interventions

Raltegravir Film-coated Tabletdrug

Raltegravir Chewable Tabletdrug

Other Anti-Retroviral Therapydrug

At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing