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Zidovudine

Phase 1

HIV Infections | Small molecule | Infectious Disease |Amgen 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002255An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)PHASE1 COMPLETED - - -Jun 24, 20051 United States
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Study Design & Arms
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
FilgrastimDRUG -
Epoetin alfaDRUG -
ZidovudineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria Concurrent Medication: Allowed: * Ganciclovir (DHPG) for treatment of CMV infections. Concurrent Treatment: Allowed: * Radiotherapy or laser therapy for Kaposi's sarcoma lesions provided dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm total b...

Countries:United States
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