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NCT00000634 · ClinicalTrials.gov registry record · NA
A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT00000634: Completed NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000634 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000634, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children. Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
Interventions
- DRUG Nevirapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Phase | NA |
What the finished NCT00000634 record still lists
NCT00000634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Nevirapine is the first listed.
NCT00000634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000634 about?
NCT00000634 is a clinical study titled "A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children". To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single dose...
What is the current status of trial NCT00000634?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants.
What interventions are being tested in trial NCT00000634?
The interventions under investigation include: Nevirapine (DRUG).
Who is sponsoring clinical trial NCT00000634?
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 NCT00000634's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 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