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

Approved Data Requests Associated with this Trial

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.