Completed
Fluconazole and Amphotericin B for Relapse Prevention in AIDS-Related Cryptococcal Meningitis
What is being tested
Fluconazole
+ Amphotericin B
Drug
Who is being recruted
Blood-Borne Infections+26
+ Neuroinflammatory Diseases
+ Urogenital Diseases
Over 18 Years
+26 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 two medications, Fluconazole (UK-49,858) and Amphotericin B, to find out which one works better and safer for preventing the relapse of a specific type of meningitis called cryptococcal meningitis in patients with AIDS. The importance of this study lies in identifying a more effective and safer treatment option for AIDS patients who are at risk of this meningitis relapse, thus potentially improving their care and quality of life.
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
8 inclusion criteria required to participate
Antivirals such as zidovudine (AZT)
Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy
Patients must be oriented to person, place, and time, and able to give written informed consent
Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry
Show More Criteria
18 exclusion criteria prevent from participating
Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research
Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis
Barbiturates
Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis
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 39 locations
Univ of Alabama at Birmingham
Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google MapsTucson Veterans Administration Med Ctr
Tucson, United StatesDr Richard Meyer
Los Angeles, United StatesDavies Med Ctr
San Francisco, United StatesCompleted39 Study Centers