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

Phase 2

Terminated

• Conditions: Cryptococcal Meningitis
• Interventions: Biological: placebo; Biological: Efungumab (Mycograb); Biological: Amphotericin B; Biological: 5 flucytosine

• Registration Number: NCT00847678
• Lead Sponsor: Novartis Pharmaceuticals

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); 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2007-11
• Status Verified: 2009-02
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Last Update Submitted: 2009-02-18
• Study First Posted: 2009-02-19
• Last Update Posted: 2009-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	5 flucytosine	Mycograb + Amphotericin B + 5 flucytosine
2	placebo	Placebo + Amphotericin B + 5 flucytosine
1	Efungumab (Mycograb)	Mycograb + Amphotericin B + 5 flucytosine
1	Amphotericin B	Mycograb + Amphotericin B + 5 flucytosine
2	Amphotericin B	Placebo + Amphotericin B + 5 flucytosine
2	5 flucytosine	Placebo + Amphotericin B + 5 flucytosine
3	Efungumab (Mycograb)	Mycograb + Amphotericin B
3	Amphotericin B	Mycograb + Amphotericin B

Primary Outcome Measures

Name	Time	Method
proportion of patients (receiving Mycograb + Amphotericin B + 5-flucytosine) cured (combined clinical and microbiological response) versus placebo (Amphotericin B + 5-flucytosine) and versus Mycograb + Amphotericin B alone.	day 14

Secondary Outcome Measures

Name	Time	Method
Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.	week 10
Assess the cerebrospinal fluid (CSF) penetration of Mycograb	Days 3, 7 and 14
Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity.	Day 14

Trial Locations

Locations (1)

Novartis Investigative Site; 🇿🇦 South Africa, South Africa