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NCT00001111 · ClinicalTrials.gov registry record · NA
A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT00001111: Completed NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001111 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001111, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and preliminary activity of nevirapine administered alone in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the safety, tolerance, and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to less than 2 months. Combination therapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and preliminary activity of nevirapine administered in combination with zidovudine (AZT) in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years. Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.
Interventions
- DRUG Zidovudine
- DRUG Nevirapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Phase | NA |
What the finished NCT00001111 record still lists
NCT00001111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Zidovudine is the first listed.
NCT00001111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001111 about?
NCT00001111 is a clinical study titled "A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children". Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and preliminary activity of nevirapine administered alone in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the safety, tolerance, and pharmacokine...
What is the current status of trial NCT00001111?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants.
What interventions are being tested in trial NCT00001111?
The interventions under investigation include: Zidovudine (DRUG), Nevirapine (DRUG).
Who is sponsoring clinical trial NCT00001111?
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 NCT00001111's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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