drugset / Trial / NCT00324025

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

NCT00324025

Phase 2 Terminated 3 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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/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.

Timeline

Start
2007-03
Primary completion
2007-09
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Efungumab Monoclonal antibody 1 mg/kg Intravenous