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atazanavir boosted with ritonavir

Phase 1

HIV Infection | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Sep 22, 2015

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02034838Microboosting of Atazanavir 300 mg With 50 mg Versus 100mg Ritonavir Daily in HIV-infected Patients: a Pharmacokinetic StudyPHASE1 COMPLETED 12Jan 1, 2014Sep 1, 2015Sep 22, 20151 Canada
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Study Endpoints
Primary Endpoints
Pharmacokinetics
9 days

main pharmacokinetic parameters of atazanavir: AUC0-24h, Cmax and Cmin.

Secondary Endpoints
adverse events
9 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
atazanavir 300mg boosted with ritonavir 100mgEXPERIMENTALTwo period drug interaction. Period one: atazanavir 300mg boosted with ritonavir 100 mg once daily as part of current treatment standard of care. Period two: atazanavir 300 mg boosted with ritonavir 50 mg once daily for study days 2-8 inclusive
Interventions
NameTypeDescription
atazanavir 300mg boosted with ritonavir 50 mgDRUGatazanavir 300 mg with ritonavir 100 mg once a day at 8:00 am for study day 1 and 9. atazanavir 300 mg with ritonavir 50 mg once a day at 8:00 am for 7 consecutive days (study days 2-8)
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients meeting the following criteria will be eligible for participation in this study: 1. Signed informed consent prior to any study-related activities. 2. Documented HIV infection. 3. Male or female patients between 18 and 70 years of age inclusively. 4. Medicatio...

Countries:Canada
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