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)

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

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

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

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

Beth Israel Deaconess Med. Ctr., ACTG CRS; 🇺🇸 Boston, Massachusetts, United States

Regional Center for Infectious Disease, Wendover Medical Center CRS; 🇺🇸 Greensboro, North Carolina, United States

The Ohio State Univ. AIDS CRS; 🇺🇸 Columbus, Ohio, United States

Hosp. of the Univ. of Pennsylvania CRS; 🇺🇸 Philadelphia, Pennsylvania, United States

Pitt CRS; 🇺🇸 Pittsburgh, Pennsylvania, United States

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

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

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

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

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

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

SUNY - Buffalo, Erie County Medical Ctr.; 🇺🇸 Buffalo, New York, United States

Washington U CRS; 🇺🇸 Saint Louis, Missouri, United States

St. Louis ConnectCare, Infectious Diseases Clinic; 🇺🇸 Saint Louis, Missouri, United States

Beth Israel Med. Ctr. (Mt. Sinai); 🇺🇸 New York, New York, United States

Carolinas HealthCare System, Carolinas Med. Ctr.; 🇺🇸 Charlotte, North Carolina, United States

Univ. of Rochester ACTG CRS; 🇺🇸 Rochester, New York, United States

Univ. of Cincinnati CRS; 🇺🇸 Cincinnati, Ohio, United States

Cornell University A2201; 🇺🇸 New York, New York, United States

Unc Aids Crs; 🇺🇸 Chapel Hill, North Carolina, United States