Trials
Search / Trial NCT00001017

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

Aids Related Opportunistic Infections Meningitis Injections, Intravenous Cryptococcosis Fluconazole Administration, Oral Acquired Immunodeficiency Syndrome Amphotericin B

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.

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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