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A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections



A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

For Condition: Mycoses,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Immunostimulants under studies carried out under an IRB approved protocol. - Treatments of intercurrent non-fungal infection. - Allowed but requires monitoring during fluconazole therapy: - Barbiturates. - Phenytoin. - Oral hypoglycemics. - Coumarin-type anticoagulants. Patients must have the following: - Diagnosis or presumption of fungal infection under defined conditions. - Written informed consent either from the patient or the patient's legal guardian. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Burns > 30 percent of the body. - Diagnosis of AIDS or AIDS related complex (ARC). - HIV positive unless they have a malignancy. - History of allergy to or intolerance of imidazoles or azoles. - Moderate to severe liver disease as defined by specific lab values. - Unlikely to survive more than 24 hours. - Evidence of previous amphotericin B sensitivity. Concurrent Medication: Excluded: - Concomitant antifungal agents other than the study drugs. - Immunostimulants, except for studies carried out under an IRB approved protocol. Concurrent Treatment: Excluded: - Lymphocyte replacements. Patients with the following are excluded: - Defined disease conditions listed in Exclusion Co-Existing Conditions. - Unlikely to survive more than 24 hours. - Previous participation in this study; reentry for the same infection is not allowed. - Known to be unable to take amphotericin B due to acute toxicities. Prior Medication: Excluded: - Previous fluconazole therapy for this infection.
Total Enrollment: 

Location and Contact Information:

Dr Layne Gentry
Houston,  Texas,  77030
United States
 

Dr Temple Williams
Houston,  Texas,  77030
United States
 

M D Anderson Cancer Ctr
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:
  012N;  056-173
Study Start Date: 
Record last reviewed: December 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002277

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