A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
Condition: HIV-1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Intervention description: Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/
      Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of
      care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive
      participants as determined by the proportion of virologic responders defined as having
      (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of
             the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody
             positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1
             ribonucleic acid (RNA) viral load greater than or equal to (>=) 5,000 copies per
             milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1
             RNA viral load (>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once
             within 1 week of initial HIV-1 RNA viral load test

          -  Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure
             prophylaxis (PrEP)

          -  Must be able to swallow whole tablets

          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during the study and for 90 days after receiving the last dose of study
             drug

          -  A woman of childbearing potential must have a negative urine pregnancy test at
             screening

        Exclusion Criteria:

          -  Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium
             tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining
             condition that in the judgement of the investigator would increase the risk of
             morbidity or mortality

          -  Known history of clinically relevant hepatic disease or hepatitis that in the
             investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/
             Tenofovir Alafenamide (D/C/F/TAF FDC)

          -  Known history of cirrhosis as diagnosed based on local practices

          -  Known history of chronic ([>=] 3 months) renal insufficiency, defined as having an
             estimated glomerular filtration rate (eGFR) less than (<) 50 milliliter per minute
             (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula

          -  Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this
             study or within 90 days after the last dose of study treatment