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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006325
The ClinicalTrials.gov registry entry for NCT00006325 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 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 1 intervention - of which Peginterferon alfa-2b is the first listed.
NCT00006325 reports 0 study locations.
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.
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