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

Cryptococcal Meningitis Clinical Trial

Official title:

A Multicenter, Randomized Study to Assess the Efficacy and Safety of Mycograb® as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00847678
• Other study ID #: MYC123A2201
• Secondary ID: NTP/Mycograb/003
• Status: Terminated
• Phase: Phase 2
• First received: February 18, 2009
• Last updated: February 18, 2009
• Start date: August 2006

Study information

• Verified date: February 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryptococcal Meningitis
• Meningitis
• Meningitis, Cryptococcal

Intervention

Biological:
• Efungumab (Mycograb)

• placebo

• Amphotericin B

• 5 flucytosine

Locations

Country	Name	City	State
South Africa	Novartis Investigative Site	South Africa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.		week 10	Yes
Secondary	Assess the cerebrospinal fluid (CSF) penetration of Mycograb		Days 3, 7 and 14	No
Secondary	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	No