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 AreaAnti-Infectives for Systemic UseEnrollment27% Female52.4%% White6%
Product ClassAntivirals for Systemic UseSponsor 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

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.