Study Phase 3

A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

Trial Information

Generic NameDarunavirProduct NamePREZISTA®Therapeutic AreaAnti-Infectives for Systemic UseProduct ClassAntivirals for Systemic UsePharmacological SubgroupDirect Acting AntiviralsChemical SubgroupAntivirals for Treatment of HIV Infections, CombinationsCondition StudiedHIV Infections
Sponsor Protocol NumberTMC114IFD3013 - WK48Enrollment1149Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)45.1% 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

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