Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Collaborating Sponsors:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Meningitis, Cryptococcal

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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...

Detailed Description

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) amp...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

330 Patients enrolled

Trial Details

Trial ID

NCT00001017

Last Update

March 14 2011

Active Locations (28)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 7 (28 locations)

1

UCLA CARE Ctr

Los Angeles, California, United States, 90095

2

Univ of Miami School of Medicine

Miami, Florida, United States, 331361013

3

Indiana Univ Hosp

Indianapolis, Indiana, United States, 462025250

4

Louisiana State Univ School of Medicine

New Orleans, Louisiana, United States, 70112