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GW640385

Phase 2

Infection, Human Immunodeficiency Virus I | Small molecule | Infectious Disease |GSK plc|Last Updated: May 30, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00257621GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected AdultsPHASE2 COMPLETED 30 — — Oct 1, 2004Jan 1, 2007May 30, 20179 United States
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Study Endpoints
Primary Endpoints
Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.
throughout the study
Secondary Endpoints
Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure.
throughout the study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
GW640385DRUG -
RitonavirDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: * HIV-1 infected subjects. * Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception. * Plasma HIV-1 RNA (viral load) \>/=1,000 copies/mL at Screening. * CD4+ cell count \>/=...

Countries:United States
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