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Amphotericin B

Phase 3

HIV Infections | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Jun 24, 2005

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002159A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or HistoplasmosisPHASE3 COMPLETED 60 - -Jun 24, 20059 United States
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Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
ItraconazoleDRUG -
Amphotericin BDRUG -
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Eligibility Criteria
Age Range13 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria Patients must have: * HIV positive or negative status. * Blastomycosis or histoplasmosis. * Life expectancy of at least 1 week. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Liver disease. * Self-limiting fungal ...

Countries:United States
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