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NCT00885703 · ClinicalTrials.gov registry record · Phase 1
High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 168
- Enrollment target
NCT00885703: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00885703 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 168 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00885703, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 168 participants
- Enrollment target
Study Summary
Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal cord, caused by the fungus Cryptococcus neoformans. CM most often affects people with compromised immune systems, like those with advanced HIV infection. This study explored the safety, tolerability, and therapeutic effect of a new treatment regimen with high-dose fluconazole for management of CM in HIV-infected patients.
Primary Outcome
Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2 Discontinuation includes discontinuing for any reason, including progression of symptoms, death, etc.
Interventions
- DRUG Fluconazole
- DRUG Amphotericin B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2010-04-16 |
| Est. Completion | 2017-01-12 |
| Phase | Phase 1 |
What the finished NCT00885703 record still lists
NCT00885703 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluconazole is the first listed.
NCT00885703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00885703 about?
NCT00885703 is a clinical study titled "High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals". Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal cord, caused by the fungus Cryptococcus neoformans. CM most often affects people with compromised immune systems, like those with advanced HIV infection. This study explored the safety, tolerability, and ther...
What is the current status of trial NCT00885703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 168 participants. The study started on 2010-04-16. Estimated completion is 2017-01-12.
What interventions are being tested in trial NCT00885703?
The interventions under investigation include: Fluconazole (DRUG), Amphotericin B (DRUG).
Who is sponsoring clinical trial NCT00885703?
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 NCT00885703's enrollment target sits among peer trials
168 326th of 2000 higher than 1,671 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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