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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cryptococcal Meningitis

In brief

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/kg) or placebo during the first week of induction therapy (amphotericin B plus 5-flucytosine) via a central line or peripheral venous line twice daily for 7 consecutive days. The total duration of the study will be approximately 24 months.

Key facts

Study ID

NCT00324025

Run by

Novartis Pharmaceuticals

People needed

3

Starts

2007-03-01

Expected to finish

2007-09-01

Last updated by the study team

2008-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama School of Medicine — Birmingham, Alabama, United States
• Department of Medicine/Infectious Disease, MC 7881, University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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