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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 randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to receive either Mycograb® (dosed 1 mg...

Detailed Description

This multicenter, randomized, double-blind, parallel-group clinical trial is designed to evaluate Mycograb® versus placebo as adjunctive therapy to antifungal induction therapy (amphotericin B plus 5-...

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 :

    March 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2007

    Estimated Enrollment :

    3 Patients enrolled

    Trial Details

    Trial ID

    NCT00324025

    Start Date

    March 1 2007

    End Date

    September 1 2007

    Last Update

    December 12 2008

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Alabama School of Medicine

    Birmingham, Alabama, United States, 35233

    2

    Department of Medicine/Infectious Disease, MC 7881, University of Texas Health Science Center

    San Antonio, Texas, United States, 78229