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Zidovudine

Phase 1

HIV Infections | Small molecule | Infectious Disease |Novartis AG|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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002006A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and FeasibilityPHASE1 COMPLETED - - -Jun 24, 20051 United States
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Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
ZidovudineDRUG -
SargramostimDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria Concurrent Treatment: Allowed: * Minimal local irradiation for tumors. Patients must have: * Diagnosis of AIDS or AIDS related complex (ARC). * Neutropenia, due either to zidovudine (AZT) or HIV infection. * Life expectancy = or \> 6 months. Exclusion Criteria Co-existing C...

Countries:United States
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