Status:
TERMINATED
Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cryptococcal Meningitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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);...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00847678
Start Date
August 1 2006
Last Update
February 19 2009
Active Locations (1)
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1
Novartis Investigative Site
South Africa, South Africa