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Zidovudine

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Nov 4, 2021

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 Trials3
Total Enrollment2,223
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00000637A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected ChildrenPHASE3 COMPLETED 819 -Sep 1, 1996Nov 2, 202180 United States, Puerto Rico
NCT00000671A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine TreatmentPHASE2 COMPLETED 750 - -Mar 14, 201171 United States, Puerto Rico
NCT00001029A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the PastPHASE2 COMPLETED 654 -May 1, 1993Nov 4, 202137 United States, Puerto Rico +1
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Study Design & Arms
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
ZidovudineDRUG -
DidanosineDRUG -
ZalcitabineDRUG -
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Eligibility Criteria
Age Range3 Months — 17 Years
SexALL
Healthy VolunteersNo
Study Sites80

Inclusion Criteria Concurrent Medication: Allowed: * Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for \> 72 hours. * Systemic ketoconazole and fluconazole for acute therapy. Recommended: * Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamid...

Countries:United StatesPuerto RicoTanzania
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