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Tenofovir DF

Phase 3

HIV Infection | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Jul 10, 2008

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00234910Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected PatientsPHASE3 COMPLETED 152Jan 1, 2005Jun 1, 2008Jul 10, 20081 United States
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Study Endpoints
Primary Endpoints
Antiviral efficacy by HIV RNA
72 wks
Incidence of adverse events
72 wks
Secondary Endpoints
Adherence and quality of life
72 wks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL2 drug arm
BACTIVE_COMPARATOR3 drug arm, SOC
Interventions
NameTypeDescription
Tenofovir DFDRUGTDF 300mg QD for 72 wks
lopinavir/ritonavir with 2 Nucleoside RTIsDRUGLPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * HIV positive * \>18 years of age * HIV RNA\> 400 copies/mL * Any CD 4 cell count * Antiretroviral naïve * No acute illness Exclusion Criteria: \-

Countries:United States
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