Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

Completed · Phase 3

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

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.

Key facts

Study ID

NCT00001017

Run by

Pfizer

People needed

330

Last updated by the study team

2011-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA CARE Ctr — Los Angeles, California, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Louisiana State Univ School of Medicine — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• City Hosp Ctr at Elmhurst / Mount Sinai Hosp — Elmhurst, New York, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• SUNY - Stony Brook — Stony Brook, New York, United States
• Jack Weiler Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
• Montefiore Med Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
• North Central Bronx Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
• Bronx Veterans Administration / Mount Sinai Hosp — The Bronx, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Holmes Hosp / Univ of Cincinnati Med Ctr — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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