Study Phase 3

A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.

Trial Information

Generic NameRilpivirineProduct NameEDURANT®Therapeutic AreaImmune System DiseasesEnrollment680% Female27.1%% White61%
Product ClassAntiviral AgentSponsor Protocol NumberTMC278-TIDP6-C215Data 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

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