Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Mycograb® as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
2 other identifiers
interventional
3
1 country
2
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to receive either Mycograb® (dosed 1 mg/kg) or placebo during the first week of induction therapy (amphotericin B plus 5-flucytosine) via a central line or peripheral venous line twice daily for 7 consecutive days. The total duration of the study will be approximately 24 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2007
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2006
CompletedFirst Posted
Study publicly available on registry
May 10, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 12, 2008
December 1, 2008
6 months
May 8, 2006
December 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of patients cured (combined clinical and microbiological response) versus placebo
Day 14
Secondary Outcomes (2)
Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.
Week 10
Assess the cerebrospinal fluid (CSF) penetration of Mycograb
Days 3, 7 and 14
Study Arms (2)
1
EXPERIMENTALMycograb
2
ACTIVE COMPARATORbiological
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Excluded for coma, or significant other medical conditions. Subject has other opportunistic fungal infections that requires other systemic antifungal therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Alabama School of Medicine
Birmingham, Alabama, 35233, United States
Department of Medicine/Infectious Disease, MC 7881, University of Texas Health Science Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals, MD
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2006
First Posted
May 10, 2006
Study Start
March 1, 2007
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
December 12, 2008
Record last verified: 2008-12