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

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT02431247 Not Available
  • Notebook for Primary Citation Primary Citation
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameDarunavirProduct NamePREZISTA®Therapeutic AreaViral DiseasesEnrollment725% Female11.70%%% White71.40%%
Product ClassAntiviral AgentSponsor Protocol NumberTMC114FD2HTX3001 - WK48Data PartnerJohnson & JohnsonCondition StudiedHIV InfectionsMean/Median Age (Years)34

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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