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GW810781

Phase 2

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Feb 21, 2013

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00046332A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected PatientsPHASE2 COMPLETED 100Jun 1, 2002Jan 1, 2003Feb 21, 201323 United States
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Study Endpoints
Primary Endpoints
Plasma HIV-1 RNA change from baseline by Day 11.
Secondary Endpoints
HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GW810781DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * No prior HIV medications. * HIV infection with viral load \>400-50,000 copies/mL. * CD4 cell count \>50 cells/mm. Exclusion Criteria: * Patients requiring medications that cannot be interrupted for the duration of the study. * Abnormal ECG or other chronic health conditions ...

Countries:United States
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