Study Phase 2

A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose Response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV

Trial Information

Generic NameDarunavirProduct NamePREZISTA®Therapeutic AreaAnti-Infectives for Systemic UseProduct ClassAntivirals for Systemic UsePharmacological SubgroupDirect Acting AntiviralsChemical SubgroupProtease InhibitorsCondition StudiedHIV Infections
Sponsor Protocol NumberTMC114-C202Enrollment330Data PartnerJohnson & Johnson% Female25%Mean/Median Age (Years)45% WhiteN/A

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.