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NCT00001017 · ClinicalTrials.gov registry record · Phase 3
Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
NCT00001017 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 330 participants.
The verdict
NCT00001017, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study Summary
To compare the safety and effectiveness of a new drug, fluconazole, with that of the usual therapy, amphotericin B, in the prevention of a relapse of cryptococcal meningitis (CM) in patients with AIDS who have been successfully treated for acute CM in the last 6 months. Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug.
Interventions
- DRUG Fluconazole
- DRUG Amphotericin B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001017
The ClinicalTrials.gov registry entry for NCT00001017 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fluconazole is the first listed.
NCT00001017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001017 about?
NCT00001017 is a clinical study titled "Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS". To compare the safety and effectiveness of a new drug, fluconazole, with that of the usual therapy, amphotericin B, in the prevention of a relapse of cryptococcal meningitis (CM) in patients with AIDS who have been successfully treated for acute CM in the last 6 months. Cryptococcal meningitis is a...
What is the current status of trial NCT00001017?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants.
What interventions are being tested in trial NCT00001017?
The interventions under investigation include: Fluconazole (DRUG), Amphotericin B (DRUG).
Who is sponsoring clinical trial NCT00001017?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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