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Stavudine

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
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,130
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00116298Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)PHASE3 COMPLETED 900Jan 1, 2001Jan 1, 2005Apr 25, 201163 United States, Argentina +14
NCT00000789A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV InfectionPHASE2 COMPLETED 230 -Jul 1, 1998Nov 4, 202154 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period
Secondary Endpoints
Efficacy: Changes in CD4 cell counts
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
stavudine, efavirenz, lamivudineDRUG -
StavudineDRUG -
ZidovudineDRUG -
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Eligibility Criteria
Age Range3 Months — 6 Years
SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: * Completed d4T studies AI455-096 or AI455-099 * Have demonstrated compliance with the study medication and treatment visits * Provide written informed consent * Agree to use a barrier method of birth control (such as condoms) during the study * Have a negative pregnancy test wi...

Countries:United StatesArgentinaBelgiumBrazilCanadaFranceIsraelItalyMexicoPortugalPuerto RicoRussiaSingaporeSouth AfricaSpainThailand
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