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Atazanvir/ritonavir + efavirenz

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 14, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00135343A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing RegimenPHASE3 COMPLETED 60Apr 1, 2004Oct 1, 2005Apr 14, 201115 United States
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Study Endpoints
Primary Endpoints
Mean percent change from baseline in fasting plasma triglycerides at Week 8
Secondary Endpoints
Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
Interventions
NameTypeDescription
Atazanvir/ritonavir + efavirenzDRUGCapsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Provide written informed consent * HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3 * Antiretroviral (ARV) naive prior to enrollment * Normal plasma triglycerides ≤ 200 mg/dL * Women of child-bearing age must use effective ba...

Countries:United States
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