Completed
Fluconazole Treatment Safety and Effectiveness for Acute Cryptococcal Meningitis in AIDS and Non-AIDS Patients
What is being tested
Fluconazole
Drug
Who is being recruted
Blood-Borne Infections+26
+ Neuroinflammatory Diseases
+ Urogenital Diseases
Over 18 Years
+24 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on the treatment of acute cryptococcal meningitis, a severe infection of the brain membranes, in both AIDS and non-AIDS patients. The main goal is to evaluate the safety and effectiveness of a medication called fluconazole. This study is important because it aims to find a satisfactory treatment for this condition, which can be challenging to manage, especially in patients with AIDS. The study includes both newly diagnosed and relapsed patients.
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCentral Nervous System DiseasesCentral Nervous System InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycosesNervous System DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMeningitis, FungalCentral Nervous System Fungal InfectionsAcquired Immunodeficiency SyndromeCryptococcosisMeningitisHIV InfectionsMeningitis, CryptococcalAIDS-Related Opportunistic Infections
Criteria
7 inclusion criteria required to participate
Concurrent radiation therapy for mucocutaneous Kaposi's sarcoma
Concurrent use of antivirals such as zidovudine (AZT)
Concurrent use of prophylaxis for Pneumocystis carinii pneumonia (including aerosolized pentamidine)
Patient's treatment status must be one of the following: No prior systemic antifungal therapy for cryptococcosis or relapse after prior therapy. The success of prior therapy must have been documented by negative CSF culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into the study
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17 exclusion criteria prevent from participating
A history of allergy to or intolerance of imidazoles or azoles
Concurrent use of barbiturates
Concurrent use of coumarin-type anticoagulants
Concurrent use of immunostimulants
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Saint Michael's Med Ctr
Newark, United StatesSUNY / Health Sciences Ctr at Brooklyn
Brooklyn, United StatesCabrini Med Ctr
New York, United StatesCompleted4 Study Centers