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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Cryptococcal Meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Mycograb + Amphotericin B + 5 flucytosine

Group Type EXPERIMENTAL

Efungumab (Mycograb)

Intervention Type BIOLOGICAL

Amphotericin B

Intervention Type BIOLOGICAL

5 flucytosine

Intervention Type BIOLOGICAL

2

Placebo + Amphotericin B + 5 flucytosine

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

Amphotericin B

Intervention Type BIOLOGICAL

5 flucytosine

Intervention Type BIOLOGICAL

3

Mycograb + Amphotericin B

Group Type EXPERIMENTAL

Efungumab (Mycograb)

Intervention Type BIOLOGICAL

Amphotericin B

Intervention Type BIOLOGICAL

Interventions

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Efungumab (Mycograb)

Intervention Type BIOLOGICAL

placebo

Intervention Type BIOLOGICAL

Amphotericin B

Intervention Type BIOLOGICAL

5 flucytosine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No