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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847678
First Posted: February 19, 2009
Last Update Posted: February 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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

Condition Intervention Phase
Cryptococcal Meningitis Biological: Efungumab (Mycograb) Biological: placebo Biological: Amphotericin B Biological: 5 flucytosine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Study to Assess the Efficacy and Safety of Mycograb® as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS

Resource links provided by NLM:


Further study details as provided by Novartis:

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. [ Time Frame: day 14 ]

Secondary Outcome Measures:
  • Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events. [ Time Frame: week 10 ]
  • Assess the cerebrospinal fluid (CSF) penetration of Mycograb [ Time Frame: 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. [ Time Frame: Day 14 ]

Enrollment: 38
Study Start Date: August 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mycograb + Amphotericin B + 5 flucytosine
Biological: Efungumab (Mycograb) Biological: Amphotericin B Biological: 5 flucytosine
Placebo Comparator: 2
Placebo + Amphotericin B + 5 flucytosine
Biological: placebo Biological: Amphotericin B Biological: 5 flucytosine
Experimental: 3
Mycograb + Amphotericin B
Biological: Efungumab (Mycograb) Biological: Amphotericin B

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847678


Locations
South Africa
Novartis Investigative Site
South Africa, South Africa
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00847678     History of Changes
Other Study ID Numbers: MYC123A2201
NTP/Mycograb/003B
First Submitted: February 18, 2009
First Posted: February 19, 2009
Last Update Posted: February 19, 2009
Last Verified: February 2009

Keywords provided by Novartis:
Cryptococcal Meningitis

Additional relevant MeSH terms:
Meningitis
Meningitis, Cryptococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Central Nervous System Infections
Amphotericin B
Liposomal amphotericin B
Flucytosine
Antibodies, Monoclonal
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs