Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00847678

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 II

MedlinePlus related topics: Meningitis

Drug Information available for: Mycograb Amphotericin B Flucytosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title:	A Multicenter, Randomized Study to Assess the Efficacy and Safety of Mycograb® as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS

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
1: Experimental Mycograb + Amphotericin B + 5 flucytosine	Biological: Efungumab (Mycograb) Biological: Amphotericin B Biological: 5 flucytosine
2: Placebo Comparator Placebo + Amphotericin B + 5 flucytosine	Biological: placebo Biological: Amphotericin B Biological: 5 flucytosine
3: Experimental 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

More Information

No publications provided

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

Keywords provided by Novartis:

Cryptococcal Meningitis

Study placed in the following topic categories:

Antimetabolites
Abelcet
Amphotericin B
Meningitis, Fungal
Clotrimazole
Miconazole
Tioconazole
Central Nervous System Diseases
Flucytosine

Liposomal amphotericin B
Meningitis
Anti-Bacterial Agents
Mycoses
Central Nervous System Infections
Antifungal Agents
Meningitis, Cryptococcal
Central Nervous System Fungal Infections
Cryptococcosis

Additional relevant MeSH terms:

Antimetabolites
Abelcet
Anti-Infective Agents
Amphotericin B
Antiprotozoal Agents
Meningitis, Fungal
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Central Nervous System Diseases
Flucytosine
Liposomal amphotericin B
Pharmacologic Actions

Meningitis
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Central Nervous System Infections
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Meningitis, Cryptococcal
Amebicides
Central Nervous System Fungal Infections
Cryptococcosis

ClinicalTrials.gov processed this record on May 07, 2009