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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000983
The ClinicalTrials.gov registry entry for NCT00000983 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 400 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 Zidovudine is the first listed.
NCT00000983 reports 0 study locations.
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.
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