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
BRAAVE 2020
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
1 other identifier
interventional
496
1 country
82
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2018
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2020
CompletedResults Posted
Study results publicly available
August 27, 2020
CompletedSeptember 5, 2021
August 1, 2021
12 months
August 13, 2018
August 12, 2020
August 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 24
Secondary Outcomes (9)
Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
Week 48
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
Week 24
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set
Week 24
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
Week 48
Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set
Baseline to Week 24
- +4 more secondary outcomes
Study Arms (2)
B/F/TAF
EXPERIMENTALParticipants will receive B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF
ACTIVE COMPARATORParticipants will stay on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (82)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Alabama Medical Group, PC
Mobile, Alabama, 36608, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036, United States
Mills Clinical Research
Los Angeles, California, 90069, United States
Highland Hospital- Alameda Health System
Oakland, California, 94602, United States
Kaiser Permanente
Oakland, California, 94611, United States
One Community Health
Sacramento, California, 95811, United States
Kaiser Permanente
Sacramento, California, 95825, United States
Kaiser Permanente, Department of Infectious Diseases
San Leandro, California, 94577, United States
Whitman-Walker Health
Washington D.C., District of Columbia, 20005, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009, United States
Washington Health Institute
Washington D.C., District of Columbia, 20017, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, 20036, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720, United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308, United States
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, 33316, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982, United States
AHF- The Kinder Medical Group
Miami, Florida, 33133, United States
University of Miami School of Medicine Division of Infectious Disease
Miami, Florida, 33136, United States
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, 33140, United States
Orlando Immunology Center
Orlando, Florida, 32803-1851, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, 33614, United States
AIDS Research & Treatment Center of the Treasure Coast
Vero Beach, Florida, 32960, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33407, United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308, United States
Atlanta ID Group, PC
Atlanta, Georgia, 30309, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Infectious Disease Specialist of Atlanta
Decatur, Georgia, 30033, United States
Mercer University, Department of Internal Medicine
Macon, Georgia, 31201, United States
Chatham County Health Department
Savannah, Georgia, 31401, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
NorthStar Medical Center
Chicago, Illinois, 60657, United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, 46077, United States
University Medical Center- New Orleans (UMCNO)
New Orleans, Louisiana, 70112, United States
SLVHCS Building J, 7th floor, Outpatient Infectious Disease Clinic
New Orleans, Louisiana, 70119, United States
CrescentCare Health
New Orleans, Louisiana, 70130, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Claudia T. Martorell, MD, LLC d/b/a The Research Institute
Springfield, Massachusetts, 01105, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Wayne State University- Integrative Bioscience Center
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. John Newland Medical Associates
Southfield, Michigan, 48075, United States
Hennepin County Medical Center, Positive Care Clinic
Minneapolis, Minnesota, 55414, United States
G.V. 'Sonny' Montgomery VAMC
Jackson, Mississippi, 39216, United States
Southampton Clinical Research
St Louis, Missouri, 63108, United States
Clinical: Saint Louis University, New Hope Clinic
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Southampton Healthcare, Inc.
St Louis, Missouri, 63139, United States
Huntridge Family Clinic
Las Vegas, Nevada, 89104, United States
Prime Healthcare Services- St. Michael's LLC d/b/a Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, 11030, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
NC TraCS Institute-CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
UT Physicians
Charlotte, North Carolina, 28207, United States
Duke University Health System
Durham, North Carolina, 27710, United States
East Carolina University, The Brody School of Medicine, ECU Adult Specialty Care
Greenville, North Carolina, 27834, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
AHF
Pensacola, North Carolina, 32504, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19066, United States
Philadelphia FIGHT Community Health Centers
Philadelphia, Pennsylvania, 19107, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
St. Hope Foundation
Bellaire, Texas, 77401, United States
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, 75208, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, 75246, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, United States
Therapeutic Concepts, PA
Houston, Texas, 77004, United States
Thomas Street Health Center
Houston, Texas, 77030, United States
Research Access Network
Houston, Texas, 77098, United States
The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA)
Houston, Texas, 77098, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Community Health Care, Hilltop Medical Clinic
Tacoma, Washington, 98405, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (5)
Andreatta K, D'Antoni ML, Chang S, Parvangada A, Martin R, Blair C, et al. Preexisting Resistance and Week 48 Virologic Outcomes after Switching to B/F/TAF in African American Adults With HIV [Presentation]. IDWeek Virtual; 2020b 21-25 October.
RESULTHagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Week-48 Outcomes From the BRAAVE 2020 Study: a Randomized Switch to B/F/TAF in African-American Adults With HIV, IDWeek 2020, October 21-25. Abstract 1046.
RESULTAndreatta K, D'Antoni ML, Chang S, Martin R, Blair C, Collins SE, et al. Preexisting Resistance and B/F/TAF Switch Efficacy in African Americans [Poster 509]. Conference on Retroviruses and Opportunistic Infections (CROI); 2020b 08-11 March; Boston, MA.
RESULTHagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Randomized Switch to B/F/TAF in African American Adults with HIV. Conference on Retroviruses and Opportunistic Infections 2020, March 7-11, Boston MA. Abstract 2979.
RESULTHagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopal MN, McDonald C, Blair C, Andreatta K, Collins SE, Brainard DM, Martin H; BRAAVE2020 Investigators. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study. J Acquir Immune Defic Syndr. 2021 Sep 1;88(1):86-95. doi: 10.1097/QAI.0000000000002731.
PMID: 34397746RESULT
MeSH Terms
Interventions
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 15, 2018
Study Start
August 28, 2018
Primary Completion
August 12, 2019
Study Completion
August 19, 2020
Last Updated
September 5, 2021
Results First Posted
August 27, 2020
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.