Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS

A Multicenter, Randomized Study to Assess the Efficacy and Safety of Mycograb® as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS

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

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