Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
Launched by PFIZER · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 g...
Gender
ALL
Eligibility 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.
Trial Officials
Armstrong D
Study Chair
Dismukes W
Study Chair
Powderly W
Study Chair
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Bronx, New York, United States
Bronx, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Columbus, Ohio, United States
West Columbia, South Carolina, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Miami, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Buffalo, New York, United States
Elmhurst, New York, United States
Stony Brook, New York, United States
Los Angeles, California, United States
New York, New York, United States
New Orleans, Louisiana, United States
New York, New York, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
New Orleans, Louisiana, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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