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GS-9137 - A Novel HIV-1 Integrase Inhibitor

Phase 2

HIV | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jul 29, 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
RandomizedDouble-BlindUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment278
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00298350Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.PHASE2 COMPLETED 278Feb 1, 2006Jul 1, 2007Jul 29, 200854 United States, Puerto Rico
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GS-9137 - A Novel HIV-1 Integrase InhibitorDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * HIV RNA greater than or equal to 1000 c/mL. * Failed/Failing protease inhibitor based antiretroviral therapy. * Stable antiretroviral therapy for greater than or equal to 30 days prior to screening. * Negative Serum Pregnancy Test. * GFR by Cockcroft Gault greater than or equa...

Countries:United StatesPuerto Rico
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