A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
Condition: Immunodeficiency Virus Type 1, Human
MeSH terms: Immunologic Deficiency Syndromes
Intervention: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC; DRV/COBI FDC; FTC/TDF FDC; D/C/F/TAF FDC - Matching Placebo; FTC/TDF FDC Matching Placebo; DRV/COBI FDC Matching Placebo
Intervention description: A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily.; A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily.; A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily.; Matching placebo of D/C/F/TAF FDC will be administered once daily.; Matching placebo of FTC/TDF FDC will be administered once daily.; Matching placebo of DRV/COBI FDC will be administered once daily.
Intervention MeSH terms: Tenofovir; Emtricitabine; Darunavir; Cobicistat; Emtricitabine tenofovir alafenamide; Cobicistat mixture with darunavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 725.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immunodeficiency Virus Type 1, Human; Darunavir; Cobicistat; Tenofovir Alafenamide; Emtricitabine; Tenofovir Disoproxil Fumarate

Summary:

      The purpose of this study is to demonstrate non-inferiority in efficacy of a
      darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination
      (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with
      Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1
      (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV
             including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any
             approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any
             length of time

          -  Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or equal to >=1,000
             copies per milliliter (copies/mL)

          -  Cluster of Differentiation 4+ (CD4+) cell count >50 cells/microliter (cells/mcL)

          -  Screening HIV-1 genotype report must show full sensitivity to DRV, TDF and FTC

          -  Screening eGFRcreatinine >=70 mL/min according to the Cockcroft-Gault formula for
             creatinine clearance

        Exclusion Criteria:

          -  Subject has been diagnosed with a new acquired immunodeficiency syndrome
             (AIDS)-defining condition within the 30 days prior to screening

          -  Subject has proven or suspected acute hepatitis within 30 days prior to screening

          -  Subject is hepatitis C or hepatitis B positive

          -  Subject has a history of cirrhosis