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Videx EC

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Feb 17, 2010

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment254
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00135382Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based RegimenPHASE3 COMPLETED 254Jun 1, 2002Oct 1, 2005Feb 17, 201048 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Efficacy at week 48
Secondary Endpoints
Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Videx ECDRUG -
EpivirDRUG -
SustivaDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Documented HIV infection * ≥ 18 years of age and weight at least 40kg * Two plasma HIV RNA levels \< 50 copies/mL during the qualification and screening period * Patients receiving a PI and ≥ 2 NRTIs Exclusion Criteria: * Pregnancy or breastfeeding * Documented virologic fai...

Countries:United StatesPuerto Rico
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