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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000967
The ClinicalTrials.gov registry entry for NCT00000967 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 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 2 interventions - of which Zidovudine is the first listed.
NCT00000967 reports 0 study locations.
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.
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