Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Pfizer.
NCT00001017 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 330 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00001017 record still lists
NCT00001017 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluconazole is the first listed.
NCT00001017 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001017's enrollment target sits among peer trials
330 1066th of 2000 higher than 927 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00359684 · 330 participants
Use of Cysteamine in the Treatment of Cystinosis
- NCT03817502 · 330 participants · Phase 3
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
- NCT03922724 · 330 participants · Phase 2
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
- NCT03932773 · 330 participants · NA
Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD