Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
Condition: HIV-1 Infection
Intervention: RTV; ATV; DRV; COBI; ATV/co; DRV/co; FTC/TDF; ABC/3TC; B/F/TAF
Intervention description: 100 mg capsule coadministered orally with ATV or DRV once daily with food; 300 mg capsule administered orally once daily with food; 800 mg tablet administered orally once daily with food; 150 mg tablet coadministered orally with ATV or DRV once daily with food; 300/150 mg FDC tablet administered orally once daily with food; 800/150 mg FDC tablet administered orally once daily with food; 200/300 mg FDC tablet administered orally once daily without regard to food; 600/300 mg tablet administered orally once daily with or without regard to food; 50/200/25 mg FDC tablet administered orally once daily without regard to food
Intervention MeSH terms: Cobicistat mixture with darunavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 578.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose
      combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus
      continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either
      emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in
      HIV-1 infected adults who are virologically suppressed.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently receiving a once daily antiretroviral regimen consisting of ritonavir or
             cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for ≥ 6 months preceding
             the screening visit

          -  Adequate renal function:

               -  Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) according to the
                  Cockcroft-Gault formula

          -  Life expectancy ≥ 1 year

          -  Currently on a stable regimen for ≥ 6 months preceding the screening visit with
             documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months preceding the screening
             visit (or undetectable HIV-1 RNA level according to the local assay being used if the
             limit of detection is ≥ 50 copies/mL). Prior changes in antiretroviral regimen are
             only allowed due to tolerability issues or for regimen simplification. Unconfirmed
             virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior
             to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA
             assay is < 50 copies/mL [e.g., < 20 copies/mL], the plasma HIV-1 RNA level cannot
             exceed 50 copies/mL on two consecutive HIV-1 RNA tests)

          -  Have no documented or suspected resistance to FTC, tenofovir, ABC or 3TC, including
             but not limited to the reverse transcriptase resistance mutations K65R and M184V/I

          -  No previous use of any approved or experimental integrase strand transfer inhibitor
             (INSTI)

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening

          -  Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
             variceal bleeding)

          -  Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3
             months of study screening, or expected to receive these agents or systemic steroids
             during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine
             based therapies)

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance

          -  A history of or ongoing malignancy (including untreated carcinoma in-situ) other than
             cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive
             cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are
             eligible, but must not have received any systemic therapy for KS within 30 days of Day
             1 and are not anticipated to require systemic therapy during the study

          -  Active, serious infections (other than HIV 1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to Day 1

          -  Participation in any other clinical trial, including observational studies, without
             prior approval from the sponsor is prohibited while participating in this trial

          -  Any other clinical condition or prior therapy that, in the opinion of the
             Investigator, would make the individual unsuitable for the study or unable to comply
             with the dosing requirements

          -  Any known allergies to the excipients of B/F/TAF FDC or ATV, RTV, DRV, COBI, FTC/TDF
             or ABC/3TC

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

          -  Acute hepatitis in the 30 days prior to study entry

          -  Chronic hepatitis B infection in individuals not on a TDF containing regimen, as
             determined by either:

               -  Positive hepatitis B virus (HBV) surface antigen and negative HBV surface
                  antibody, regardless of HBV core antibody status, at the screening visit

               -  Positive HBV core antibody and negative HBV surface antibody, regardless of HBV
                  surface antigen status, at the screening visit

          -  Active tuberculosis infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.