Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if treatment with two medicines in combination (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for the treatment of an early infection with a fungus called cryptococcus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Bausch Health Americas, Inc.; Kenya Medical Research Institute; National Institute of Neurological Disorders and Stroke (NINDS); University of Nairobi; Valeant Pharmaceuticals International, Inc.
• Treatments: Fluconazole; Flucytosine

Criteria

Inclusion Criteria:

• Able and willing to give informed consent

• Age > 18 years

• HIV infection as confirmed by HIV-antibody test as per Kenyan guidelines

• CD4+ T-cell count ≤100 cells/µl

• Serum CrAg titer≥1:2

• Able to travel to district hubs (Sindo District Hospital, Lumumba Health Centre) for regular study visits

Exclusion Criteria:

• clinical meningitis:

• clinical sepsis:

• hemiparesis, aphasia, visual field deficit or other finding on neurological examination localizable to the central nervous system

• a history of culture proven or suspected (cryptococcal antigen present) cryptococcal meningitis

• a history of stroke or other infection of the central nervous system

• a seizure within the last 2 months

• currently taking or ever taken antiretroviral therapy

• currently taking anti-tuberculous therapy

• currently or recently (<2 months) prescribed fluconazole, itraconazole, clotrimazole troches, amphotericin or other oral anti-fungal medications

• pregnant or breast-feeding

• alanine aminotransferase concentration more than 3 times the upper limit of normal

• neutrophil count <1000x103 cells/mL

• hemoglobin <8g/dL

• platelet count <100,000x 103 platelets/mL

• creatinine clearance ≤50 ml/min

• individuals with active heavy alcohol use or active recreational drug use