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NCT00000983 · ClinicalTrials.gov registry record · Phase 2
The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
NCT00000983: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000983 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 400 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (201% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000983, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
Study Summary
To evaluate and compare differences in tolerance and side effects associated with two different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are differences in the rate and degree of toxicities associated with one versus the other dosage. AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.
Interventions
- DRUG Zidovudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Est. Completion | 1994-12 |
| Phase | Phase 2 |
What the finished NCT00000983 record still lists
NCT00000983 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (201% higher).
The record links to 0 conditions, and to 1 intervention - of which Zidovudine is the first listed.
NCT00000983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000983 about?
NCT00000983 is a clinical study titled "The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children". To evaluate and compare differences in tolerance and side effects associated with two different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are diffe...
What is the current status of trial NCT00000983?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. Estimated completion is 1994-12.
What interventions are being tested in trial NCT00000983?
The interventions under investigation include: Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00000983?
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 NCT00000983's enrollment target sits among peer trials
400 96th of 2000 higher than 1,898 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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