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Amphotericin B

Phase 3

Meningitis, Cryptococcal | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 14, 2011

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment330
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00001017Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDSPHASE3 COMPLETED 330 - -Mar 14, 201128 United States
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Study Design & Arms
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
FluconazoleDRUG -
Amphotericin BDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria * HIV infection documented by antibody (ELISA on two occasions or ELISA with Western blot confirmation), p24 antigen testing, or recovery of HIV in culture. Prior Medication: Required: * Minimum total dose of 15 mg/kg of amphotericin B (either alone or in combination with fluc...

Countries:United States
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