CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 153 enrolled
Drug / intervention
Raltegravir poloxamer film coated tablet +3 moredrug
Likely dose
Raltegravir oral granules for suspension (20 mg/mL)from 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/NCT00485264
NCT00485264Phase 2Completed
CompareCT.gov

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 Antiviral Activity of Raltegravir (Isentress, MK-0518) in HIV-1 Infected Children and Adolescents

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 12, 2007·Updated Nov 2, 2021

In Brief

A Phase 2 clinical trial evaluating Raltegravir poloxamer film coated tablet, Raltegravir chewable tablet, and 1 other intervention for HIV Infections. Completed, enrolled 153 participants across 42 sites in 6 countries.

Detailed Summary

Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Botswana, Brazil, Puerto Rico, South Africa, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2007
Enrollment StartSep 17, 2007
Primary CompletionJun 3, 2013
Study CompletionMay 18, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 19.1 years ago

Interventions

Raltegravir poloxamer film coated tabletdrug

Final Selected Dose: 400-mg tablet taken orally twice daily.

Raltegravir chewable tabletdrug

Final Selected Dose: Weight based dose of \~6 mg/kg according to the dosing table, to a maximum dose of 300 mg, taken orally twice daily.

Raltegravir oral granules for suspension (20 mg/mL)drug

Weight based dose of \~6 mg/kg orally every 12 hours according to dosing table in protocol or the dose determined by review of all available data.

Raltegravir poloxamer film coated tabletdrug

Final Selected Dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg. Participants \< 25 kg were switched to a weight-based dose of the chewable tablet.