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Lamivudine/Zidovudine

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: May 4, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002429Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug RegimenPHASE3 COMPLETED 500Jul 1, 1999Jan 1, 2001May 4, 201123 United States, Canada
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Study Design & Arms
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Lamivudine/ZidovudineDRUG -
Nelfinavir mesylateDRUG -
StavudineDRUG -
DidanosineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria Patients may be eligible for this study if they: * Are HIV-positive. * Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3. * Are at least 18 years old. * Agree to practice sexual abstinence or to use effective barrier methods of birth control...

Countries:United StatesCanada
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