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NCT00485264 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT00485264 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 153 participants.
The verdict
NCT00485264, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study 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.
Interventions
- DRUG Raltegravir poloxamer film coated tablet
- DRUG Raltegravir chewable tablet
- DRUG Raltegravir oral granules for suspension (20 mg/mL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2007-09-17 |
| Est. Completion | 2017-05-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00485264
The ClinicalTrials.gov registry entry for NCT00485264 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Raltegravir poloxamer film coated tablet is the first listed.
NCT00485264 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00485264 about?
NCT00485264 is a clinical study titled "Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents". 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 adoles...
What is the current status of trial NCT00485264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2007-09-17. Estimated completion is 2017-05-18.
What interventions are being tested in trial NCT00485264?
The interventions under investigation include: Raltegravir poloxamer film coated tablet (DRUG), Raltegravir chewable tablet (DRUG), Raltegravir oral granules for suspension (20 mg/mL) (DRUG).
Who is sponsoring clinical trial NCT00485264?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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