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NCT00145249 · ClinicalTrials.gov registry record · Phase 2
Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
NCT00145249: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00145249 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00145249, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
Study Summary
This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will look at whether study participants recover more quickly and have fewer side effects if they are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as compared to the standard treatment. Participants will be followed for approximately 6 months from the time they are enrolled into the study.
Primary Outcome
Events are reported by MedDRA Preferred Term. Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention. Grade 4 - Life-threatening. AE is life-threatening. Grade 5 - Death. AE causes death.
Interventions
- DRUG Fluconazole
- DRUG Amphotericin B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-04 |
| Phase | Phase 2 |
What the finished NCT00145249 record still lists
NCT00145249 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Fluconazole is the first listed.
NCT00145249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00145249 about?
NCT00145249 is a clinical study titled "Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis". This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 wee...
What is the current status of trial NCT00145249?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2005-05. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00145249?
The interventions under investigation include: Fluconazole (DRUG), Amphotericin B (DRUG).
Who is sponsoring clinical trial NCT00145249?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00145249's enrollment target sits among peer trials
143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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