Recent Updates
Recently added Catalysts

fosamprenavir

Phase 3

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Feb 12, 2013

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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00043888Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIRPHASE3 COMPLETED 60Jan 1, 2002May 1, 2003Feb 12, 201318 United States, France +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To assess the overall short term tolerance of the regimens under investigation
Secondary Endpoints
Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
fosamprenavirDRUG -
COMBIVIRDRUG -
ritonavirDRUG -
TRIZIVIRDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range13 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL. * Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter. * Antiretroviral therapy naive (no prior therapy allowed). * Male or female 13 years of ag...

Countries:United StatesFranceUnited Kingdom
Unlock Eligibility Criteria