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NCT00000747 · ClinicalTrials.gov registry record · Phase 2
An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00000747 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants.
The verdict
NCT00000747, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3. Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts \<= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
Interventions
- DRUG Nevirapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000747
The ClinicalTrials.gov registry entry for NCT00000747 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 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.
NCT00000747 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000747 about?
NCT00000747 is a clinical study titled "An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3". Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3. Secondary: To evaluate the effect of nevirapine on surrogate markers. The an...
What is the current status of trial NCT00000747?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants.
What interventions are being tested in trial NCT00000747?
The interventions under investigation include: Nevirapine (DRUG).
Who is sponsoring clinical trial NCT00000747?
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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