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| Sponsor: | Pfizer |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001017 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis, Cryptococcal HIV Infections |
Drug: Fluconazole Drug: Amphotericin B |
Phase III |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome |
| Estimated Enrollment: | 330 |
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.
Patients accepted in the trial are randomly assigned to fluconazole or amphotericin B. Fluconazole is given orally once a day and amphotericin B is given intravenously once a week. Dosages depend on body weight. Medications may be given with amphotericin B to prevent or reduce discomfort from associated side effects. Patients are treated for 12 months and may continue to receive antiviral therapy, radiation therapy for mucocutaneous Kaposi's sarcoma, or preventive therapy for Pneumocystis carinii pneumonia (PCP) during the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Prior Medication:
Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded for more than 7 days after initiation of primary therapy for cryptococcosis:
Prior Treatment:
Excluded:
Contacts and Locations| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Louisiana State Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| North Central Bronx Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Beth Israel Med Ctr / Peter Krueger Clinic | |
| New York, New York, United States, 10003 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| SUNY - Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Holmes Hosp / Univ of Cincinnati Med Ctr | |
| Cincinnati, Ohio, United States, 452670405 | |
| Univ Hosp of Cleveland / Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Study Chair: | Armstrong D | |
| Study Chair: | Dismukes W | |
| Study Chair: | Powderly W |
More Information
| Study ID Numbers: | ACTG 026, 056-158, FDA 12E |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001017 History of Changes |
| Health Authority: | Unspecified |
|
AIDS-Related Opportunistic Infections Meningitis Injections, Intravenous Cryptococcosis |
Fluconazole Administration, Oral Acquired Immunodeficiency Syndrome Amphotericin B |
|
Abelcet Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Liposomal amphotericin B Meningitis Anti-Bacterial Agents Mycoses Antiparasitic Agents Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Meningitis, Cryptococcal Central Nervous System Fungal Infections |
Amebicides Retroviridae Infections Fluconazole Amphotericin B RNA Virus Infections Meningitis, Fungal Immune System Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Central Nervous System Diseases Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Central Nervous System Infections HIV Infections |