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 UseProduct ClassAntivirals for Systemic UsePharmacological SubgroupDirect Acting AntiviralsChemical SubgroupProtease InhibitorsCondition StudiedHIV Infections
Sponsor Protocol NumberTMC114-C212Enrollment80Data PartnerJohnson & Johnson% Female29.0%Mean/Median Age (Years)14.0% White63.0%

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

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