Study Phase 1

A Phase I, Partially Randomized, Open Label, Two-way, Two Period Cross-over Study to Investigate the Pharmacokinetic Interaction Between Etravirine or Darunavir/Rtv and Artemether/Lumefantrine at Steady-state in Healthy HIV-negative Subjects

Trial Information

Generic NameEtravirineProduct NameINTELENCE®Therapeutic AreaImmune System DiseasesEnrollment33% FemaleN/A% WhiteN/A
Product ClassAntiviral AgentSponsor Protocol NumberTMC125VIR1001Data PartnerJohnson & JohnsonCondition StudiedHIV InfectionsMean/Median Age (Years)27

Supporting Documentation

  • Collected Datasets Available
  • Analysis Datasets Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial


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.