Study Phase 3

A Phase III, Randomized, Double-blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects

Trial Information

Generic NameRilpivirineProduct NameEDURANT®Therapeutic AreaImmune System DiseasesEnrollment694% Female21.3%% White61%
Product ClassAntiviral AgentSponsor Protocol NumberTMC278-TIDP6-C209Data PartnerJohnson & JohnsonCondition StudiedHIV InfectionsMean/Median Age (Years)36

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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