Study Phase 3

A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 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 NumberTMC114FD2HTX3001 - WK48Enrollment725Data PartnerJohnson & Johnson% Female11.7%Mean/Median Age (Years)34.00% White71.4%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification 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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