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

Primary Purpose

Cryptococcal Meningitis

Status

Terminated

Phase

Phase 2

Locations

South Africa

Study Type

Interventional

Intervention

Efungumab (Mycograb)

placebo

Amphotericin B

5 flucytosine

About this trial

This is an interventional treatment trial for Cryptococcal Meningitis focused on measuring Cryptococcal Meningitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

Mycograb + Amphotericin B + 5 flucytosine

Placebo + Amphotericin B + 5 flucytosine

Mycograb + Amphotericin B

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.

Assess the cerebrospinal fluid (CSF) penetration of Mycograb

Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity.

Full Information

NCT ID

NCT00847678

First Posted

February 18, 2009

Last Updated

February 18, 2009

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00847678

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Terminated

Study Start Date

August 2006 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cryptococcal Meningitis

Keywords

Cryptococcal Meningitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Mycograb + Amphotericin B + 5 flucytosine

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo + Amphotericin B + 5 flucytosine

Arm Title

Arm Type

Experimental

Arm Description

Mycograb + Amphotericin B

Intervention Type

Biological

Intervention Name(s)

Efungumab (Mycograb)

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Type

Biological

Intervention Name(s)

Amphotericin B

Intervention Type

Biological

Intervention Name(s)

5 flucytosine

Primary Outcome Measure Information:

Title

Time Frame

day 14

Secondary Outcome Measure Information:

Title

Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.

Time Frame

week 10

Title

Assess the cerebrospinal fluid (CSF) penetration of Mycograb

Time Frame

Days 3, 7 and 14

Title

Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity.

Time Frame

Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

South Africa

Country

South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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