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LPV/r +2 NRTIs

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Feb 5, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment192
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00120393Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/RitonavirPHASE3 COMPLETED 192 — — Jan 1, 2004May 1, 2006Feb 5, 201014 United States, Canada
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Study Endpoints
Primary Endpoints
To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.
Secondary Endpoints
Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
Mean change in cholesterol measures at Weeks 12, 24 and 48.
Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
G1ACTIVE_COMPARATOR -
G2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
atazanavir/ritonavir +2 NRTIs (immediate Switch Group)DRUGCapsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
LPV/r +2 NRTIs (Delayed/optional Switch Group)DRUGCapsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * HIV positive * LPV/RTV-based HAART for at least 6 months * HIV-1 RNA less than 50c/mL (confirmed) * Non-HDL higher than 160 mg/dL * CD4 of at least 50 cells/mL Exclusion Criteria: * Use of lipid-lowering agents

Countries:United StatesCanada
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Competitive Landscape -Bacterial Infections 62 trials
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