Recent Updates
Recently added Catalysts

Kaletra

Phase 2

HIV Infections | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Oct 2, 2006

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00075231A Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected SubjectsPHASE2 COMPLETED 150Dec 1, 2003 -Oct 2, 20061 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Kaletra® (lopinavir/ritonavir)DRUG -
Combivir® (lamivudine, zidovudine)DRUG -
Sustiva® (efavirenz)DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Subject is at least 18 years of age. * Subject is confirmed HIV positive and in the investigator's opinion requires antiretroviral (ARV) therapy. * Subject is naïve to HIV ARV therapy or has received \< 7 days total of any HIV ARV therapy \> 30 days prior to study drug administ...

Countries:United States
Unlock Eligibility Criteria