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NCT00000967 · ClinicalTrials.gov registry record · Phase 1
The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT00000967: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000967 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000967, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in combination with AZT. SECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic parameters; to determine whether the pharmacokinetic parameters of AZT are modified by the subcutaneous administration of IFN-A. AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment of two drugs that work together may provide more effective and safer treatment. IFN-A is a drug that has antiviral effects and may work well with AZT.
Interventions
- DRUG Zidovudine
- DRUG Interferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Est. Completion | 1996-09 |
| Phase | Phase 1 |
What the finished NCT00000967 record still lists
NCT00000967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000967 about?
NCT00000967 is a clinical study titled "The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children". PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in combination with AZT. SECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic para...
What is the current status of trial NCT00000967?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. Estimated completion is 1996-09.
What interventions are being tested in trial NCT00000967?
The interventions under investigation include: Zidovudine (DRUG), Interferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00000967?
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 NCT00000967's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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