Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
Condition: HIV-1 Infection
Intervention: B/F/TAF; NRTIs; Third Agent
Intervention description: 50/200/25 mg FDC tablets administered orally once daily without regard to food; The following NRTIs will be administered as prescribed until Week 24 without regard to food:
abacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT); Any one of the following third agents will be administered as prescribed. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir. :
Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
delavirdine (DLV)
efavirenz (EFV)
nevirapine (NVP)
rilpivirine (RPV)
doravirine (DOR)
Integrase inhibitors
dolutegravir (DTG)
elvitegravir (EVG)
raltegravir (RAL)
Protease inhibitors (PIs)
atazanavir (ATV)
darunavir (DRV)
lopinavir (LPV)
nelfinavir NFV)
saquinavir (SQV)
tipranavir (TPV)
Chemokine co-recptor 5 (CCR5) antagonist --maraviroc (MVC)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 496.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching from a regimen
      of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose
      combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus
      continuing their baseline regimen in HIV-1 infected, virologically suppressed African
      American participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Self-describes as Black, African American, or mixed race, including Black

          -  Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that
             consists of any two NRTIs + allowed 3rd agent for ≥ 6 months

          -  Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir,
             any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the
             CCR5 antagonist, maraviroc

          -  If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is
             excluded

          -  Baseline regimens containing investigational drugs or > 2 classes of ARVs are not
             permitted, with the exception of the pharmacologic enhancers cobicistat (taken with
             elvitegravir or a PI), or ritonavir (taken with a PI)

          -  Have no documented or suspected resistance to INSTIs and no history of virologic
             failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after
             achieving <50 copies/mL while on an INSTI-containing regimen)

          -  History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT
             substitutions are allowed, with the following exceptions: History of 3 or more TAMs
             (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT
             will be excluded

          -  Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen
             for a minimum period of 6 months and at least the last two HIV-1 RNA measurements
             prior to the Screening visit

          -  HIV-1 RNA levels < 50 copies/mL at Screening

          -  Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the
             Cockcroft-Gault formula for creatinine clearance

        Key Exclusion Criteria:

          -  History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and
             K219Q/E/N/R),T69-insertions, or K65R/E/N in RT

          -  No desire to switch from current ARVs

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening

          -  Participants experiencing decompensated cirrhosis (e.g., 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)

          -  Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma,
             completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive
             cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix
             (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for
             which there has been no evidence of disease for at least five years prior to screening
             is allowed

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with participant study compliance

          -  Active, serious infections (other than HIV-1 infection) requiring 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 participant unsuitable for the study or unable to comply
             with the dosing requirements

          -  Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation
             excipient

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

          -  Acute hepatitis in the 30 days prior to randomization

          -  Active tuberculosis infection.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.