Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus 5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study will be approximately 24 months
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or non-pregnant female who is > 18 years old.
- HIV-positive or unknown, with acute, either first or recurrent episode of cryptococcal meningitis.
- Currently on no treatment, or receiving treatment (< 3 days) with either amphotericin B plus 5-flucytosine, or amphotericin B alone.
- Positive CSF culture for Cryptococcus neoforman.
- Physical signs and symptoms of meningitis, evidenced by one or more of the following: fever, headache, meningeal signs and neurologic findings.
Exclusion criteria
- Excluded for coma, or significant other medical conditions.
- Subject has other opportunistic fungal infections that requires other systemic antifungal therapies.
Other protocol-defined inclusion/exclusion criteria may apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
38 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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