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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001017
First received: November 2, 1999
Last updated: March 11, 2011
Last verified: September 2002

November 2, 1999
March 11, 2011
Not Provided
July 1991   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00001017 on ClinicalTrials.gov Archive Site
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Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

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.

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.

Interventional
Phase 3
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Meningitis, Cryptococcal
  • HIV Infections
  • Drug: Fluconazole
  • Drug: Amphotericin B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
Not Provided
July 1991   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001017
ACTG 026, 056-158, FDA 12E
Not Provided
Not Provided
Pfizer
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Armstrong D
Study Chair: Dismukes W
Study Chair: Powderly W
National Institute of Allergy and Infectious Diseases (NIAID)
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP