Completed
Fluconazole for Maintenance Treatment of Cryptococcal Meningitis in AIDS Patients
What is being tested
Fluconazole
Drug
Who is being recruted
Blood-Borne Infections+26
+ Neuroinflammatory Diseases
+ Urogenital Diseases
Over 18 Years
+30 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 comparing the safety and effectiveness of a medication called fluconazole versus a placebo. The goal is to find out which one works better at preventing the relapse of a specific type of meningitis, known as cryptococcal meningitis, in patients diagnosed with AIDS. The importance of this study lies in its potential to improve the treatment and care for individuals affected by this condition, helping to manage the challenges associated with it.
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
11 inclusion criteria required to participate
Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of cryptococcus from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry.
Patients must be oriented to person, place, and time and able to give written informed consent.
Allowed concurrent treatments include radiation therapy for mucocutaneous Kaposi's sarcoma.
Allowed prior medications include antiviral therapy (e.g., zidovudine (AZT)) and prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
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19 exclusion criteria prevent from participating
Prior use of coumarin-type anticoagulants.
Prior use of barbiturates.
Concurrent use of coumarin-type anticoagulants.
Prior use of intrathecal amphotericin B.
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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 5 locations
UCI Med Ctr
Orange, United StatesUCSD
San Diego, United StatesDr Paul Rothman
Sherman Oaks, United StatesCompleted5 Study Centers