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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 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 35 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001111
The ClinicalTrials.gov registry entry for NCT00001111 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 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 2 interventions - of which Zidovudine is the first listed.
NCT00001111 reports 0 study locations.
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.
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