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Home > "C" Clinical Trials Conditions > Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients with AIDS  Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients with AIDS
Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients with AIDS
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Pfizer , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 330
Location and Contact Information:
Overall Study Official:
ArmstrongD, Study Chair,
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Louisiana State Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: ACTG 026; 056-158,FDA 12E
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001017
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2. Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients with 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)
3. Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
4. A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
5. The Safety of Tenofovir Disoproxil Fumarate Taken with Other Anti-HIV Drugs to Treat HIV-Infected Patients
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Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients with AIDS
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