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Rifabutin

Phase 3

Mycoses | Small molecule | Infectious Disease |Pfizer, Inc.|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
Double-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment720
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002122A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected PatientsPHASE3 COMPLETED 720 - -Jun 24, 200512 United States
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Study Design & Arms
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
AzithromycinDRUG -
RifabutinDRUG -
FluconazoleDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria Concurrent Medication: Allowed: * Preventive therapy with isoniazid for M. tuberculosis. * Maintenance therapy for CMV retinitis. Patients must have: * HIV infection or history of an AIDS-defining condition by CDC criteria. * One documented CD4 count \< 100 cells/mm3 within 1...

Countries:United States
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