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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 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 6 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000634
The ClinicalTrials.gov registry entry for NCT00000634 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 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 Nevirapine is the first listed.
NCT00000634 reports 0 study locations.
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.
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