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efavirenz

Phase 3

HIV Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: Oct 4, 2010

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment345
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00053638A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior TherapyPHASE3 COMPLETED 345Feb 1, 2003Oct 1, 2004Oct 4, 201058 United States
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Study Endpoints
Primary Endpoints
Viral load response at 48 weeks
48 weeks
Secondary Endpoints
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics
48 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
efavirenzDRUG -
tenofovirDRUG -
abacavir/lamivudineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites58

Inclusion criteria: * Participants must be able to provide informed consent. * Have documented HIV-1 infection. * Have not received more than 14 days of prior treatment with antiretroviral drugs. * Meet laboratory test criteria. * Women of childbearing potential must abstain from sexual intercourse...

Countries:United States
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