Study Phase 2

A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/Rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents

Trial Information

Generic NameDarunavirProduct NamePREZISTA®Therapeutic AreaAnti-Infectives for Systemic UseEnrollment80% Female29%% White63%
Product ClassAntivirals for Systemic UseSponsor Protocol NumberTMC114-C212Data PartnerJohnson & JohnsonCondition StudiedHIV InfectionsMean/Median Age (Years)14

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.