Clinical Trials

MainTitle

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 (BRAAVE 2020)

This study is ongoing, but not recruiting participants.
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT03631732

First received: August 13, 2018
Last updated: March 2, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-1 Infection

Drug : B/F/TAF
Drug : NRTIs
Drug : Third Agent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Open-Label 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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ]
Secondary Outcome Measures:
  • Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  • Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ]
  • Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]

Enrollment: 496
Study Start Date: August 28, 2018
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 12, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: B/F/TAF
Participants will receive B/F/TAF FDC.
Drug: B/F/TAF

50/200/25 mg FDC tablets administered orally once daily without regard to food

Other Name: Biktarvy®
Active Comparator: Stay on Baseline Regimen
Participants will stay on 2 NRTIs and a third agent until Week 24, with a delayed switch to B/F/TAF FDC at Week 24.
Drug: B/F/TAF

50/200/25 mg FDC tablets administered orally once daily without regard to food

Other Name: Biktarvy®
Drug: NRTIs
    NRTIs could include one of the following:
    • Abacavir (ABC)
    • Didanosine (ddI)
    • Emtricitabine (FTC)
    • Lamivudine (3TC)
    • Stavudine (d4T)
    • Tenofovir alafenamide (TAF)
    • Tenofovir disoproxil fumarate (TDF)
    • Zidovudine (ZDV or AZT)
    • NRTIs will be administered as prescribed until Week 24 without regard to food.

    Drug: Third Agent
      Third agent could include one of the following:
      • Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
      • Delavirdine (DLV)
      • Efavirenz (EFV)
      • Nevirapine (NVP)
      • Rilpivirine (RPV)
      • Integrase inhibitors
      • Dolutegravir (DTG)
      • Elvitegravir (EVG)
      • Raltegravir (RAL)
      • Protease inhibitors (PIs)
      • Atazanavir (ATV)
      • Darunavir (DRV)
      • Lopinavir
      • Nelfinavir NFV)
      • Saquinavir (SQV)
      • Tipranavir (TPV)
      • Third agents will be administered as prescribed without regard to food. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir.

      Eligibility

      Eligibility

      Ages Eligible for Study: 18 Years and older  
      Sexes Eligible for Study: All  
      Accepts Healthy Volunteers: No  

      Criteria

      Key Inclusion Criteria:

      • Self-describes as Black, African American, or mixed race, including Black
      • Currently receiving an 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, PI 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 antiretrovirals (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)
      • 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.

      contacts and locations

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: NCT03631732

      Locations

      United States, Alabama
      University of Alabama at Birmingham
      Birmingham, Alabama, United States, 35294
      Alabama Medical Group, PC
      Mobile, Alabama, United States, 36608
      United States, California
      Kaiser Permanente Los Angeles Medical Center
      Los Angeles, California, United States, 90027
      Ruane Clinical Research Group Inc.
      Los Angeles, California, United States, 90036
      Mills Clinical Research
      Los Angeles, California, United States, 90069
      Highland Hospital- Alameda Health System
      Oakland, California, United States, 94602
      Kaiser Permanente
      Oakland, California, United States, 94611
      One Community Health
      Sacramento, California, United States, 95811
      Kaiser Permanente
      Sacramento, California, United States, 95825
      Kaiser Permanente, Department of Infectious Diseases
      San Leandro, California, United States, 94577
      United States, District of Columbia
      Whitman-Walker Health
      Washington, District of Columbia, United States, 20005
      Georgetown University Hospital
      Washington, District of Columbia, United States, 20007
      Dupont Circle Physician's Group
      Washington, District of Columbia, United States, 20009
      Washington Health Institute
      Washington, District of Columbia, United States, 20017
      Capital Medical Associates, PC
      Washington, District of Columbia, United States, 20036
      The GW Medical Faculty Associates
      Washington, District of Columbia, United States, 20037
      United States, Florida
      Midland Florida Clinical Research Center, LLC
      DeLand, Florida, United States, 32720
      Therafirst Medical Center
      Fort Lauderdale, Florida, United States, 33308
      Gary J. Richmond, M.D., P.A.
      Fort Lauderdale, Florida, United States, 33316
      Midway Immunology and Research Center
      Fort Pierce, Florida, United States, 34982
      AIDS Healthcare Foundation - South Beach
      Miami Beach, Florida, United States, 33140
      AHF- The Kinder Medical Group
      Miami, Florida, United States, 33133
      University of Miami School of Medicine Division of Infectious Disease
      Miami, Florida, United States, 33136
      Orlando Immunology Center
      Orlando, Florida, United States, 32803-1851
      St. Joseph's Hospital Comprehensive Research Institute
      Tampa, Florida, United States, 33614
      AIDS Research & Treatment Center of the Treasure Coast
      Vero Beach, Florida, United States, 32960
      Triple O Research Institute, P.A.
      West Palm Beach, Florida, United States, 33407
      United States, Georgia
      Emory Hospital Midtown Infectious Disease Clinic
      Atlanta, Georgia, United States, 30308
      Atlanta ID Group, PC
      Atlanta, Georgia, United States, 30309
      Augusta University Medical Center
      Augusta, Georgia, United States, 30912
      Infectious Disease Specialist of Atlanta
      Decatur, Georgia, United States, 30033
      Mercer University, Department of Internal Medicine
      Macon, Georgia, United States, 31201
      Chatham County Health Department
      Savannah, Georgia, United States, 31401
      United States, Illinois
      Howard Brown Health Center
      Chicago, Illinois, United States, 60613
      NorthStar Medical Center
      Chicago, Illinois, United States, 60657
      United States, Indiana
      Indiana CTSI Clinical Research Center
      Indianapolis, Indiana, United States, 46077
      United States, Louisiana
      University Medical Center- New Orleans (UMCNO)
      New Orleans, Louisiana, United States, 70112
      SLVHCS Building J, 7th floor, Outpatient Infectious Disease Clinic
      New Orleans, Louisiana, United States, 70119
      CrescentCare Health
      New Orleans, Louisiana, United States, 70130
      United States, Massachusetts
      Brigham and Women's Hospital
      Boston, Massachusetts, United States, 02115
      Boston University Medical Center
      Boston, Massachusetts, United States, 02118
      Claudia T. Martorell, MD, LLC d/b/a The Research Institute
      Springfield, Massachusetts, United States, 01105
      United States, Michigan
      Be Well Medical Center
      Berkley, Michigan, United States, 48072-3436
      Wayne State University- Integrative Bioscience Center
      Detroit, Michigan, United States, 48201
      Henry Ford Hospital
      Detroit, Michigan, United States, 48202
      St. John Newland Medical Associates
      Southfield, Michigan, United States, 48075
      United States, Minnesota
      Hennepin County Medical Center, Positive Care Clinic
      Minneapolis, Minnesota, United States, 55414
      United States, Mississippi
      G.V. 'Sonny' Montgomery VAMC
      Jackson, Mississippi, United States, 39216
      United States, Missouri
      Southampton Clinical Research
      Saint Louis, Missouri, United States, 63108
      Clinical: Saint Louis University, New Hope Clinic
      Saint Louis, Missouri, United States, 63110
      Washington University School of Medicine
      Saint Louis, Missouri, United States, 63110
      Southampton Healthcare, Inc.
      Saint Louis, Missouri, United States, 63139
      United States, Nevada
      Huntridge Family Clinic
      Las Vegas, Nevada, United States, 89104
      United States, New Jersey
      Prime Healthcare Services- St. Michael's LLC d/b/a Saint Michael's Medical Center
      Newark, New Jersey, United States, 07102
      United States, New York
      Jacobi Medical Center
      Bronx, New York, United States, 10461
      Montefiore Medical Center
      Bronx, New York, United States, 10467
      North Shore University Hospital/Division of Infectious Diseases
      Manhasset, New York, United States, 11030
      United States, North Carolina
      NC TraCS Institute-CTRC; University of North Carolina at Chapel Hill
      Chapel Hill, North Carolina, United States, 27514
      UT Physicians
      Charlotte, North Carolina, United States, 28207
      Duke University Health System
      Durham, North Carolina, United States, 27710
      East Carolina University, The Brody School of Medicine, ECU Adult Specialty Care
      Greenville, North Carolina, United States, 27834
      Rosedale Infectious Diseases
      Huntersville, North Carolina, United States, 28078
      AHF
      Pensacola, North Carolina, United States, 32504
      Wake Forest University Health Sciences
      Winston-Salem, North Carolina, United States, 27157
      United States, Ohio
      University of Cincinnati College of Medicine
      Cincinnati, Ohio, United States, 45267
      MetroHealth Medical Center
      Cleveland, Ohio, United States, 44109
      United States, Pennsylvania
      Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
      Philadelphia, Pennsylvania, United States, 19066
      Philadelphia FIGHT Community Health Centers
      Philadelphia, Pennsylvania, United States, 19107
      United States, South Carolina
      Palmetto Health Richland
      Columbia, South Carolina, United States, 29203
      United States, Tennessee
      St. Jude Children's Research Hospital
      Memphis, Tennessee, United States, 38105
      United States, Texas
      Central Texas Clinical Research
      Austin, Texas, United States, 78705
      St. Hope Foundation
      Bellaire, Texas, United States, 77401
      AIDS Arms, Inc. DBA Prism Health North Texas
      Dallas, Texas, United States, 75208
      North Texas Infectious Diseases Consultants, P.A.
      Dallas, Texas, United States, 75246
      Tarrant County Infectious Disease Associates
      Fort Worth, Texas, United States, 76104
      Therapeutic Concepts, PA
      Houston, Texas, United States, 77004
      Thomas Street Health Center
      Houston, Texas, United States, 77030
      Research Access Network
      Houston, Texas, United States, 77098
      The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA)
      Houston, Texas, United States, 77098
      DCOL Center for Clinical Research
      Longview, Texas, United States, 75605
      United States, Washington
      Community Health Care, Hilltop Medical Clinic
      Tacoma, Washington, United States, 98405
      United States, Wisconsin
      Medical College of Wisconsin
      Milwaukee, Wisconsin, United States, 53226

      Sponsors and Collaborators

      Gilead Sciences

      Investigators

      Study Director: Gilead Study Director Gilead Sciences
      More Information

      More Information


      Responsible Party: Gilead Sciences  
      ClinicalTrials.gov Identifier: NCT03631732   History of Changes  
      Other Study ID Numbers: GS-US-380-4580  
      Study First Received: August 13, 2018  
      Last Updated: March 2, 2020  
      Individual Participant Data    
      Plan to Share IPD: No  

      Studies a U.S. FDA-regulated Drug Product: Yes  
      Studies a U.S. FDA-regulated Device Product: No  

      ClinicalTrials.gov processed this data on May 24, 2020
      This information is provided by ClinicalTrials.gov.