Study Phase 2

A Phase II, Open Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of DRV in Combination With Low-Dose Ritonavir (DRV/Rtv) in Treatment-Experienced HIV-1 Infected Children From 3 Years to Below 6 Years of Age

Trial Information

Generic NameDarunavirProduct NamePREZISTA®Therapeutic AreaImmune System DiseasesEnrollment27% Female52.4%% White6%
Product ClassAntiviral AgentSponsor Protocol NumberTMC114-TiDP29-C228Data PartnerJohnson & JohnsonCondition StudiedHIV InfectionsMean/Median Age (Years)4.4

Supporting Documentation

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


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