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zidovudine, lamivudine and nevirapine

Phase 3

AIDS | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Sep 17, 2012

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
RandomizedUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment650
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00197613The Adult Antiretroviral Treatment and Resistance Study (Tshepo)PHASE3 COMPLETED 650Dec 1, 2002Dec 1, 2007Sep 17, 20121 Botswana
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Study Endpoints
Primary Endpoints
Time to Virological failure, time to grade 3 or higher toxicity.
Secondary Endpoints
Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
Interventions
NameTypeDescription
(A) zidovudine, lamivudine and nevirapineDRUG -
(B) zidovudine, lamivudine and efavirenzDRUG -
(C) zidovudine, didanosine, and nevirapineDRUG -
(D) zidovudine, didanosine, and efavirenzDRUG -
(E) stavudine, lamivudine, and nevirapineDRUG -
(F) stavudine, lamivudine and efavirenzDRUG -
Adherence Strategy Standard of Care (SOC)PROCEDURE -
Adherence Strategy Community-Based DOTPROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria:(1) HIV infection indicated by (a) positive ELISA in two separate blood samples, the second no more than eight weeks prior to randomization), (b) CD4 cell count of less than 200 cells/ml OR CD4 cell count between 201-350 with plasma HIV-1 RNA level of greater than 55,000 copies/ml...

Countries:Botswana
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