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NCT00006325 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00006325: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00006325 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006325, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
Interventions
- DRUG Peginterferon alfa-2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Est. Completion | 2004-03 |
| Phase | Phase 1 |
What the finished NCT00006325 record still lists
NCT00006325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which Peginterferon alfa-2b is the first listed.
NCT00006325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006325 about?
NCT00006325 is a clinical study titled "Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children". The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). PEG-Intron is an experimental drug that works differ...
What is the current status of trial NCT00006325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00006325?
The interventions under investigation include: Peginterferon alfa-2b (DRUG).
Who is sponsoring clinical trial NCT00006325?
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 NCT00006325's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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