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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.
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 |
What the finished NCT00485264 record still lists
NCT00485264 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher).
The record links to 0 conditions, and to 3 interventions - of which Raltegravir poloxamer film coated tablet is the first listed.
NCT00485264 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00485264's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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