Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 3 |
| 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 |
| Primary Completion Date: | July 1991 (Final data collection date for primary outcome measure) |
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
- HIV infection documented by antibody (ELISA on two occasions or ELISA with Western blot confirmation), p24 antigen testing, or recovery of HIV in culture.
Prior Medication:
Required:
- Minimum total dose of 15 mg/kg of amphotericin B (either alone or in combination with flucytosine) during primary therapy. End of primary therapy within 6 weeks of start of maintenance therapy.
- Allowed:
- Past or present antiviral therapy and prophylaxis for Pneumocystis carinii pneumonia (PCP).
- Pfizer must be notified if the patient is receiving ganciclovir at entry. Allowed with amphotericin B to treat or prevent side effects.
- Antipyretics.
- Hydrocortisone.
- Meperidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis other than cryptococcosis.
- Allergy or intolerance of imidazoles, azoles, or amphotericin B. Unable to take oral medications reliably.
Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis other than cryptococcosis.
- Allergy or intolerance of imidazoles, azoles, or amphotericin B.
Prior Medication:
Excluded for more than 7 days after initiation of primary therapy for cryptococcosis:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any other systemic imidazole or azole.
- Excluded:
- Intrathecal amphotericin B.
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drug or approved (licensed) drugs for investigational indications.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
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 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| 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 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Beth Israel Med Ctr / Peter Krueger Clinic | |
| New York, New York, United States, 10003 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| 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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00001017 History of Changes |
| Other Study ID Numbers: | ACTG 026, 056-158, FDA 12E |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 11, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
AIDS-Related Opportunistic Infections Meningitis Injections, Intravenous Cryptococcosis |
Fluconazole Administration, Oral Acquired Immunodeficiency Syndrome Amphotericin B |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Meningitis Meningitis, Cryptococcal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Central Nervous System Infections Central Nervous System Diseases |
Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections Mycoses Cryptococcosis Amphotericin B Liposomal amphotericin B Fluconazole Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents |
ClinicalTrials.gov processed this record on May 16, 2013