A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Al… (NCT00000639) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
United States400 participants
Plain-language summary
To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole.
At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
Who can participate
Age range13 Years
SexALL
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Inclusion Criteria
Concurrent Medication:
Allowed:
* Interruption of myelosuppressive therapies and/or administration of erythropoietin, at discretion of investigator, to maintain hemoglobin = or \> 7 g/dl.
* Adjunctive corticosteroids may be administered during the triazole phase for patients who develop Pneumocystis carinii pneumonia and meet the prescribed criteria.
* Hydrocortisone, not to exceed 50 mg/day, during the amphotericin phase.
* Aerosolized pentamidine or systemic chemoprophylaxis for Pneumocystis carinii pneumonia should be given to all patients with a CD4 count \< 200 cells/mm3.
* Antiretroviral drugs (including zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC)) after patient has tolerated oral triazole for one week (after 3 weeks of study treatment).
* Maintenance treatment (except for rifamycins) for other opportunistic infections such as cytomegalovirus (CMV) retinitis, cerebral toxoplasmosis or mycobacterial infections, provided that their hematologic and hepatic values are stable and they meet the entry criteria.
Concurrent Treatment:
Allowed:
\- Transfusion, at discretion of investigator, to maintain hemoglobin = or \> 7 g/dl.
Patients must have:
* HIV infection.
* Primary episode of acute cryptococcal meningitis.
* Willing to participate in the study for a full 10 weeks and either be able to give informed consent or have a family member or guardian able to give informed consent.
Prior Medication:
Allowed:
Fluconazole prophylaxis, not…
Trial details
NCT IDNCT00000639
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)