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)
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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