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Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

NCT00485264 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-11-02

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir poloxamer film coated tablet

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

DRUG

Raltegravir chewable tablet

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.

DRUG

Raltegravir oral granules for suspension (20 mg/mL)

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.

DRUG

Raltegravir poloxamer film coated tablet

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sharon A. Nachman, MD · State University of New York at Stony Brook, Health Science Center

  • Andrew Wiznia, MD · Jacobi Medical Center, Albert Einstein College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-17
Primary Completion
2013-06-03
Completion
2017-05-18

Countries

  • United States
  • Argentina
  • Botswana
  • Brazil
  • Puerto Rico
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00485264 on ClinicalTrials.gov