Study Phase 2

A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT00915655
  • Notebook for Primary Citation Primary Citation Not Available
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameDarunavirProduct NamePREZISTA®Therapeutic AreaImmune System DiseasesEnrollment12% Female66.7%% WhiteN/A
Product ClassAntiviral AgentSponsor Protocol NumberTMC114-TiDP29-C230Data PartnerJohnson & JohnsonCondition StudiedHIV InfectionsMean/Median Age (Years)14.7

Supporting Documentation

  • Collected Datasets 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.