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

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00847678
First received: February 18, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • Assess the cerebrospinal fluid (CSF) penetration of Mycograb [ Time Frame: Days 3, 7 and 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00847678     History of Changes
Other Study ID Numbers: MYC123A2201, NTP/Mycograb/003B
Study First Received: February 18, 2009
Last Updated: February 18, 2009
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

Keywords provided by Novartis:
Cryptococcal Meningitis

Additional relevant MeSH terms:
Meningitis
Meningitis, Cryptococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Amphotericin B
Liposomal amphotericin B
Flucytosine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014