Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
Public ClinicalTrials.gov record NCT00001017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00001017
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Jul 1991 (Actual)
- Completion
- Not listed
- Last update posted
- Mar 14, 2011
United States locations
- U.S. sites
- 28
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA CARE Ctr | Los Angeles | California | 90095 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Louisiana State Univ School of Medicine | New Orleans | Louisiana | 70112 | — |
| Tulane Univ School of Medicine | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | — |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess - West Campus | Boston | Massachusetts | 02215 | — |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | — |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst | New York | 11373 | — |
| Beth Israel Med Ctr / Peter Krueger Clinic | New York | New York | 10003 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Cornell Univ Med Ctr | New York | New York | 10021 | — |
| Mem Sloan - Kettering Cancer Ctr | New York | New York | 10021 | — |
| Saint Luke's - Roosevelt Hosp Ctr | New York | New York | 10025 | — |
| Mount Sinai Med Ctr | New York | New York | 10029 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY - Stony Brook | Stony Brook | New York | 117948153 | — |
| Jack Weiler Hosp / Bronx Municipal Hosp | The Bronx | New York | 10465 | — |
| Montefiore Med Ctr / Bronx Municipal Hosp | The Bronx | New York | 10467 | — |
| North Central Bronx Hosp / Bronx Municipal Hosp | The Bronx | New York | 10467 | — |
| Bronx Veterans Administration / Mount Sinai Hosp | The Bronx | New York | 10468 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Holmes Hosp / Univ of Cincinnati Med Ctr | Cincinnati | Ohio | 452670405 | — |
| Univ Hosp of Cleveland / Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| Ohio State Univ Hosp Clinic | Columbus | Ohio | 432101228 | — |
| Julio Arroyo | West Columbia | South Carolina | 29169 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 14, 2011 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00001017 live on ClinicalTrials.gov.