Recent Updates
Recently added Catalysts

LEXIVA

Phase 3

HIV Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: May 16, 2011

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment866
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00085943KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 WeeksPHASE3 COMPLETED 866May 1, 2004 -May 16, 2011119 United States, Austria +12
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.
Secondary Endpoints
Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LEXIVA (GW433908)DRUG -
RitonavirDRUG -
KALETRADRUG -
EPIVIRDRUG -
ZiagenDRUG -
Abacavir/LamivudineDRUG -
FosamprenavirDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites119

Inclusion Criteria: * HIV infected subjects that are naive to anti-HIV therapy. * History of a positive HIV test. * At least 1000 copies/mL of HIV in their blood as screening. Exclusion Criteria: * Active HIV-related diseases. * Taking other investigational drugs. * Pregnant or breastfeeding fema...

Countries:United StatesAustriaBelgiumCanadaFranceGermanyItalyLatviaLuxembourgPolandPortugalRomaniaSpainSwitzerland
Unlock Eligibility Criteria