A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

Not Applicable

Completed

• Conditions: Meningitis, Cryptococcal; HIV Infections

• Registration Number: NCT00000639
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole.

At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.

Detailed Description

At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.

Patients are selected by a randomization process to take amphotericin B intravenously (in the vein), for 14 days, and either placebo (ineffective substance) or flucytosine for 14 days. Then patients are again selected by a randomization process to take either (1) fluconazole for a total of 8 weeks plus itraconazole placebo; or (2) itraconazole for a total of 8 weeks plus fluconazole placebo.

Study Timeline

• Study Completion: 1997-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (24)

USC CRS; 🇺🇸 Los Angeles, California, United States

Ucsf Aids Crs; 🇺🇸 San Francisco, California, United States

Univ. of Miami AIDS CRS; 🇺🇸 Miami, Florida, United States

Univ. of Hawaii at Manoa, Leahi Hosp.; 🇺🇸 Honolulu, Hawaii, United States

Northwestern University CRS; 🇺🇸 Chicago, Illinois, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic; 🇺🇸 Indianapolis, Indiana, United States

Methodist Hosp. of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU; 🇺🇸 New Orleans, Louisiana, United States

Massachusetts General Hospital ACTG CRS; 🇺🇸 Boston, Massachusetts, United States

Bmc Actg Crs; 🇺🇸 Boston, Massachusetts, United States

Scroll for more (14 remaining)