Recent Updates
Recently added Catalysts

GSK364735

Phase 2

Infection, Human Immunodeficiency Virus | Small molecule | Infectious Disease |GSK plc|Last Updated: Jul 30, 2012

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00398125Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected AdultsPHASE2 COMPLETED 30 — — Nov 1, 2006Apr 1, 2007Jul 30, 201212 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in viral load
from Day 1 to Day 11
Amount of drug in blood
on Days 1 and 10.
Secondary Endpoints
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
throughout the study
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GSK364735DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion criteria: * Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL. * Baseline CD4 cell count greater than 100. * Females must be of non-childbearing potential * Not have received antiretroviral therapy in the 12 weeks prior to first dose. Exclusion crite...

Countries:United States
Unlock Eligibility Criteria