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stavudine , lamivudine, efavirenz

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 25, 2011

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 Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00135369Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily RegimenPHASE3 COMPLETED 300Sep 1, 2002Jul 1, 2005Apr 25, 201147 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
stavudine extended-release, lamivudine, efavirenzDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Documented HIV infection * 18 years of age or older and weigh at least 40 kg * Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit) * Currently receiving a standard...

Countries:United StatesPuerto Rico
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