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NCT00000664 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00000664: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000664 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000664, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who complete the initial 25-week regimen. Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone.
Interventions
- DRUG Zidovudine
- DRUG Interleukin-2, Polyethylene Glycolated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Phase | Phase 1 |
What the finished NCT00000664 record still lists
NCT00000664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000664 about?
NCT00000664 is a clinical study titled "Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals". To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV virus and antibody titers. To e...
What is the current status of trial NCT00000664?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants.
What interventions are being tested in trial NCT00000664?
The interventions under investigation include: Zidovudine (DRUG), Interleukin-2, Polyethylene Glycolated (DRUG).
Who is sponsoring clinical trial NCT00000664?
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 NCT00000664's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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