Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
Condition: Human Immunodeficiency Virus Type 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: D/C/F/TAF; Boosted Protease Inhibitor (bPI); FTC/TDF
Intervention description: Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg.; Boosted protease inhibitor (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) as per current treatment regimen.; Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
Intervention MeSH terms: HIV Protease Inhibitors; Protease Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus Type 1; Emerald; Darunavir; Cobicistat; Emtricitabine; Tenofovir Alafenamide

Summary:

      The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a
      once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine
      (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current
      regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil
      fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1
      ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter
      [copies/mL]) HIV-1 infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently being treated with a stable antiretroviral (ARV) regimen consisting of a
             boosted protease inhibitor (limited to darunavir [DRV] or atazanavir with low-dose
             ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with
             emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) only, for at least 6 consecutive
             months preceding the Screening visit

          -  On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA)
             concentrations less than (<) 50 copies per milliliter (copies/mL) or HIV-1 RNA
             undetectable by a local HIV-1 RNA test between 12 and 2 months prior to the Screening
             visit and have HIV-1 RNA <50 copies/mL at the Screening visit

          -  A single virologic elevation of greater than or equal to (>=) 50 copies/mL after
             previously reaching viral suppression between 12 and 2 months prior to Screening is
             acceptable, provided a subsequent test prior to Screening was <50 copies/mL

          -  Absence of history of failure on DRV treatment and absence of DRV
             resistance-associated mutations (RAMs), if documented historical genotypes are
             available

          -  Normal electrocardiogram (ECG) at Screening (or if abnormal, determined by the
             Investigator to be not clinically significant)

        Exclusion Criteria:

          -  A new acquired immunodeficiency syndrome (AIDS) - defining condition diagnosed within
             the 30 days prior to Screening

          -  Proven or suspected acute hepatitis within 30 days prior to study entry

          -  Hepatitis C antibody positive; however, participants previously cured of hepatitis C
             virus (HCV) infection, with documented sustained virologic response, that is,
             undetectable HCV RNA 24 weeks after the last dose of HCV treatment, are allowed to
             participate

          -  Hepatitis B surface antigen (HBsAg) positive

          -  Participants with cirrhosis as diagnosed based on local practices