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

PHASE3CompletedINTERVENTIONAL
Enrollment

496

Participants

Timeline

Start Date

August 28, 2018

Primary Completion Date

August 12, 2019

Study Completion Date

August 19, 2020

Conditions
HIV-1 Infection
Interventions
DRUG

B/F/TAF

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

DRUG

NRTIs

"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)"

DRUG

Third Agent

"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)"

Trial Locations (82)

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

11030

North Shore University Hospital/Division of Infectious Diseases, Manhasset

19066

Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania, Philadelphia

19107

Philadelphia FIGHT Community Health Centers, Philadelphia

20005

Whitman-Walker Health, Washington D.C.

20007

Georgetown University Hospital, Washington D.C.

20009

Dupont Circle Physician's Group, Washington D.C.

20017

Washington Health Institute, Washington D.C.

20036

Capital Medical Associates, PC, Washington D.C.

20037

The GW Medical Faculty Associates, Washington D.C.

27157

Wake Forest University Health Sciences, Winston-Salem

27514

NC TraCS Institute-CTRC; University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University Health System, Durham

27834

East Carolina University, The Brody School of Medicine, ECU Adult Specialty Care, Greenville

28078

Rosedale Infectious Diseases, Huntersville

28207

UT Physicians, Charlotte

29203

Palmetto Health Richland, Columbia

30033

Infectious Disease Specialist of Atlanta, Decatur

30308

Emory Hospital Midtown Infectious Disease Clinic, Atlanta

30309

Atlanta ID Group, PC, Atlanta

30912

Augusta University Medical Center, Augusta

31201

Mercer University, Department of Internal Medicine, Macon

31401

Chatham County Health Department, Savannah

32504

AHF, Pensacola

32720

Midland Florida Clinical Research Center, LLC, DeLand

32960

AIDS Research & Treatment Center of the Treasure Coast, Vero Beach

33133

AHF- The Kinder Medical Group, Miami

33136

University of Miami School of Medicine Division of Infectious Disease, Miami

33140

AIDS Healthcare Foundation - South Beach, Miami Beach

33308

Therafirst Medical Center, Fort Lauderdale

33316

Gary J. Richmond, M.D., P.A., Fort Lauderdale

33407

Triple O Research Institute, P.A., West Palm Beach

33614

St. Joseph's Hospital Comprehensive Research Institute, Tampa

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

36608

Alabama Medical Group, PC, Mobile

38105

St. Jude Children's Research Hospital, Memphis

39216

G.V. 'Sonny' Montgomery VAMC, Jackson

44109

MetroHealth Medical Center, Cleveland

45267

University of Cincinnati College of Medicine, Cincinnati

46077

Indiana CTSI Clinical Research Center, Indianapolis

48072

Be Well Medical Center, Berkley

48075

St. John Newland Medical Associates, Southfield

48201

Wayne State University- Integrative Bioscience Center, Detroit

48202

Henry Ford Hospital, Detroit

53226

Medical College of Wisconsin, Milwaukee

55414

Hennepin County Medical Center, Positive Care Clinic, Minneapolis

60613

Howard Brown Health Center, Chicago

60657

NorthStar Medical Center, Chicago

63108

Southampton Clinical Research, St Louis

63110

Clinical: Saint Louis University, New Hope Clinic, St Louis

Washington University School of Medicine, St Louis

63139

Southampton Healthcare, Inc., St Louis

70112

University Medical Center- New Orleans (UMCNO), New Orleans

70119

SLVHCS Building J, 7th floor, Outpatient Infectious Disease Clinic, New Orleans

70130

CrescentCare Health, New Orleans

75208

AIDS Arms, Inc. DBA Prism Health North Texas, Dallas

75246

North Texas Infectious Diseases Consultants, P.A., Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77030

Thomas Street Health Center, Houston

77098

Research Access Network, Houston

The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA), Houston

77401

St. Hope Foundation, Bellaire

78705

Central Texas Clinical Research, Austin

89104

Huntridge Family Clinic, Las Vegas

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90036

Ruane Clinical Research Group Inc., Los Angeles

90069

Mills Clinical Research, Los Angeles

94577

Kaiser Permanente, Department of Infectious Diseases, San Leandro

94602

Highland Hospital- Alameda Health System, Oakland

94611

Kaiser Permanente, Oakland

95811

One Community Health, Sacramento

95825

Kaiser Permanente, Sacramento

98405

Community Health Care, Hilltop Medical Clinic, Tacoma

32803-1851

Orlando Immunology Center, Orlando

02115

Brigham and Women's Hospital, Boston

02118

Boston University Medical Center, Boston

01105

Claudia T. Martorell, MD, LLC d/b/a The Research Institute, Springfield

07102

Prime Healthcare Services- St. Michael's LLC d/b/a Saint Michael's Medical Center, Newark

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY