HIV-1 InfectionPhase 3BRAAVE 2020NCT03631732
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
A Phase 3 study testing B/F/TAF, NRTIs and Third Agent in people with HIV-1 Infection, run by Gilead Sciences at 82 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- B/F/TAF, NRTIs and Third Agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 82 sitesUnited States
- Study dates
- 28 Aug 2018to 19 Aug 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
82 sites in 1 country.
82 sites in 1 country
United States82 sites
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
Atlanta ID Group, PC
Atlanta, Georgia, 30309
Augusta University Medical Center
Augusta, Georgia, 30912
Central Texas Clinical Research
Austin, Texas, 78705
St. Hope Foundation
Bellaire, Texas, 77401
Be Well Medical Center
Berkley, Michigan, 48072
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University Medical Center
Boston, Massachusetts, 02118
NC TraCS Institute-CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
UT Physicians
Charlotte, North Carolina, 28207
Howard Brown Health Center
Chicago, Illinois, 60613
NorthStar Medical Center
Chicago, Illinois, 60657
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
MetroHealth Medical Center
Cleveland, Ohio, 44109
Palmetto Health Richland
Columbia, South Carolina, 29203
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, 75208
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, 75246
Infectious Disease Specialist of Atlanta
Decatur, Georgia, 30033
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
Wayne State University- Integrative Bioscience Center
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Health System
Durham, North Carolina, 27710
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, 33316
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
East Carolina University, The Brody School of Medicine, ECU Adult Specialty Care
Greenville, North Carolina, 27834
Therapeutic Concepts, PA
Houston, Texas, 77004
Thomas Street Health Center
Houston, Texas, 77030
Research Access Network
Houston, Texas, 77098
The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA)
Houston, Texas, 77098
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, 46077
G.V. 'Sonny' Montgomery VAMC
Jackson, Mississippi, 39216
Huntridge Family Clinic
Las Vegas, Nevada, 89104
DCOL Center for Clinical Research
Longview, Texas, 75605
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036
Mills Clinical Research
Los Angeles, California, 90069
Mercer University, Department of Internal Medicine
Macon, Georgia, 31201
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, 11030
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
AHF- The Kinder Medical Group
Miami, Florida, 33133
University of Miami School of Medicine Division of Infectious Disease
Miami, Florida, 33136
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, 33140
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center, Positive Care Clinic
Minneapolis, Minnesota, 55414
Alabama Medical Group, PC
Mobile, Alabama, 36608
University Medical Center- New Orleans (UMCNO)
New Orleans, Louisiana, 70112
SLVHCS Building J, 7th floor, Outpatient Infectious Disease Clinic
New Orleans, Louisiana, 70119
CrescentCare Health
New Orleans, Louisiana, 70130
Prime Healthcare Services- St. Michael's LLC d/b/a Saint Michael's Medical Center
Newark, New Jersey, 07102
Highland Hospital- Alameda Health System
Oakland, California, 94602
Kaiser Permanente
Oakland, California, 94611
Orlando Immunology Center
Orlando, Florida, 32803-1851
AHF
Pensacola, North Carolina, 32504
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19066
Philadelphia FIGHT Community Health Centers
Philadelphia, Pennsylvania, 19107
One Community Health
Sacramento, California, 95811
Kaiser Permanente
Sacramento, California, 95825
Kaiser Permanente, Department of Infectious Diseases
San Leandro, California, 94577
Chatham County Health Department
Savannah, Georgia, 31401
St. John Newland Medical Associates
Southfield, Michigan, 48075
Claudia T. Martorell, MD, LLC d/b/a The Research Institute
Springfield, Massachusetts, 01105
Southampton Clinical Research
St Louis, Missouri, 63108
Clinical: Saint Louis University, New Hope Clinic
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Southampton Healthcare, Inc.
St Louis, Missouri, 63139
Community Health Care, Hilltop Medical Clinic
Tacoma, Washington, 98405
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, 33614
Jacobi Medical Center
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10467
AIDS Research & Treatment Center of the Treasure Coast
Vero Beach, Florida, 32960
Whitman-Walker Health
Washington D.C., District of Columbia, 20005
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009
Washington Health Institute
Washington D.C., District of Columbia, 20017
Capital Medical Associates, PC
Washington D.C., District of Columbia, 20036
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33407
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
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.
- Conditions
- HIV-1 Infection
- Being tested
- B/F/TAF, NRTIs, Third Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Also called Biktarvy®
50/200/25 mg FDC tablets administered orally once daily without regard to food
NRTIsDrug
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)
Third AgentDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| B/F/TAF | Experimental | Participants 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. Receives: Drug: B/F/TAF |
| Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF | Active comparator | Participants 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. Receives: Drug: B/F/TAF; Drug: NRTIs; Drug: Third Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Measured: 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
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.
Measured: 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
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.
Measured: 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
The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 48 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Measured: Week 48
Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set
The analysis includes values up to 1 day after permanent discontinuation of study treatment.
Measured: Baseline to Week 24
Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set
The analysis includes values up to 1 day after permanent discontinuation of study treatment.
Measured: Baseline to Week 24
Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set
The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Measured: Baseline to Week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation.
Measured: First B/F/TAF dose date up to Week 72 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'.
Measured: First B/F/TAF dose date up to Week 72 plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start28 Aug 2018
- Primary completion12 Aug 2019
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631732
- Sponsor's protocol ID
- GS-US-380-4580
- Acronym
- BRAAVE 2020
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2018
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
Hagins 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.
Andreatta 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.
Hagins 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.
Hagins 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.
PubMed 34397746
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03631732
- Acronym / sponsor ID
- BRAAVE 2020 / GS-US-380-4580
- Conditions
- HIV-1 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 27 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B/F/TAF | Experimental | Drug: B/F/TAFParticipants 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 comparator | Drug: B/F/TAF, Drug: NRTIs, Drug: Third AgentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B/F/TAFAlso: Biktarvy®50/200/25 mg FDC tablets administered orally once daily without regard to food | Drug | B/F/TAF, Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF |
| NRTIsThe 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) | Drug | Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF |
| Third AgentAny 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) | Drug | Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF |
Primary outcome
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
Time frame: Week 24
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.
9 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 48
Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set
Time frame: Baseline to Week 24
Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set
Time frame: Baseline to Week 24
Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set
Time frame: Baseline to Week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: First B/F/TAF dose date up to Week 72 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities
Time frame: First B/F/TAF dose date up to Week 72 plus 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationAndreatta 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.
- Results publicationHagins 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.
- Results publicationAndreatta 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.
- Results publicationHagins 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.
- Results publication: PubMed 34397746Hagins 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
82 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing B/F/TAF, NRTIs and Third Agent in people with HIV-1 Infection, run by Gilead Sciences at 82 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631732, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.