Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 September 26, 2012