Clinical Trials

MainTitle

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Adults Who Are Virologically Suppressed

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2017 by Gilead Sciences

Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT03110380

First received: April 7, 2017
Last updated: December 13, 2017
Last Verified: December 2017
History of Changes
Purpose

Purpose

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®; F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance as determined by the proportion of participants with human immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 50 copies/mL at Week 48

Condition Intervention Phase
HIV-1-infection

Drug : B/F/TAF
Drug : F/TAF
Drug : DTG
Drug : DTG Placebo
Drug : F/TAF Placebo
Drug : B/F/TAF Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Proportion of participants with virologic failure (HIV-1 RNA ≥ 50 copies/mL) as defined by the modified US FDA-defined snapshot algorithm [ Time Frame: Week 48 ]
Secondary Outcome Measures:
  • Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA-defined snapshot algorithm [ Time Frame: Week 48 ]
  • Change from Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Week 48 ]

Estimated Enrollment: 520
Study Start Date: June 12, 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: B/F/TAF
B/F/TAF + DTG placebo + F/TAF placebo for 48 Weeks
Drug: B/F/TAF

50/200/25 mg FDC tablet(s) administered orally once daily

Other Name: GS-9883/F/TAF
Drug: DTG Placebo

Tablet(s) administered orally once daily

Drug: F/TAF Placebo

Tablet(s) administered orally once daily

Active Comparator: DTG + F/TAF
DTG + F/TAF + B/F/TAF placebo for 48 Weeks
Drug: F/TAF

200/25 mg FDC tablet(s) administered orally once daily

Other Name: Descovy®
Drug: DTG

50 mg tablet(s) administered orally once daily

Other Name: Tivicay®
Drug: B/F/TAF Placebo

Tablet(s) administered orally once daily

Eligibility

Eligibility

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

Criteria

Key Inclusion Criteria:

  • Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:
    • ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit)
    • ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit)
  • Documented plasma HIV-1 RNA < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening visit
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure
  • Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
infection are permitted to enroll
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: NCT03110380

Contacts

Contact:   Gilead Study Team 1-833-GILEAD-0(1-833-445-3230) GS-US-380-4030@gilead.com

Locations

United States, California
Peter J. Ruane MD, Inc. Recruiting
Los Angeles, California, United States, 90036
Mills Clinical Research Recruiting
Los Angeles, California, United States, 90069
Highland Hospital - Alameda Health System Recruiting
Oakland, California, United States, 94602
University of California Davis Recruiting
Sacramento, California, United States, 95817
Kaiser Permanente Recruiting
Sacramento, California, United States, 95825
Positive Health Program SF General Hospital Recruiting
San Francisco, California, United States, 94110
Kaiser Permanente Recruiting
San Francisco, California, United States, 94118
Kaiser Permanente Recruiting
San Leandro, California, United States, 94577
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Dupont Circle Physicians Group Recruiting
Washington, District of Columbia, United States, 20009
Whitman-Walker Health Recruiting
Washington, District of Columbia, United States, 20009
Providence Hospital Center for Infectious Disease Recruiting
Washington, District of Columbia, United States, 20017
Providence Hospital Recruiting
Washington, District of Columbia, United States, 20017
The George Washington University Recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Midland Florida Clinical Research Center, LLC Recruiting
DeLand, Florida, United States, 32720
Therafirst Medical Centers Recruiting
Fort Lauderdale, Florida, United States, 33308
Gary J. Richmond,M.D.,P.A. Recruiting
Fort Lauderdale, Florida, United States, 33316
Midway Immunology & Research Center, LLC Recruiting
Fort Pierce, Florida, United States, 34982
Michael S. Somero MD A Professional Corporation Recruiting
Miami Beach, Florida, United States, 33140
University of Miami Division of Infectious Diseases Clinical Research Unit Recruiting
Miami, Florida, United States, 33136
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
AIDS Healthcare Foundation Recruiting
Pensacola, Florida, United States, 32503
Infectious Disease Research Institute Inc. Recruiting
Tampa, Florida, United States, 33614
St. Josephs Comprehensive Research Institute Recruiting
Tampa, Florida, United States, 33614
AIDS Research & Treatment Center of the Treasure Coast Recruiting
Vero Beach, Florida, United States, 32960
Triple O Research Institute PA Recruiting
West Palm Beach, Florida, United States, 33407
Rowan Tree Medical PA Recruiting
Wilton Manors, Florida, United States, 33305
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
AIDS Research Consortium of Atlanta Recruiting
Atlanta, Georgia, United States, 30312
Augusta University Research Institute Recruiting
Augusta, Georgia, United States, 30912
Infectious Disease Specialists of Atlanta, PC Recruiting
Decatur, Georgia, United States, 30033
Carolinas Medical Center--Myers Park Infectious Disease Clinic Recruiting
Macon, Georgia, United States, 31201
Chatham County Health Department Recruiting
Savannah, Georgia, United States, 31401
United States, Hawaii
John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako Recruiting
Honolulu, Hawaii, United States, 96813
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Brigham & Women's Hospital and Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02115
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Community Research Initiative of New England Recruiting
Boston, Massachusetts, United States, 02129
MetroWest Medical Center Recruiting
Framingham, Massachusetts, United States, 01702
The Research Institute Recruiting
Springfield, Massachusetts, United States, 01105
United States, Michigan
Be Well Medical Center Recruiting
Berkley, Michigan, United States, 48072
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55404
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Kansas City Care Clinic Recruiting
Kansas City, Missouri, United States, 64111
Southampton Healthcare, Inc. Recruiting
Saint Louis, Missouri, United States, 63139
United States, New Jersey
Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center Recruiting
Newark, New Jersey, United States, 07102
United States, New Mexico
Southwest CARE Center Recruiting
Albuquerque, New Mexico, United States, 87109
Southwest CARE Center Recruiting
Santa Fe, New Mexico, United States, 87505
United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
United States, North Carolina
University of North Carolina at Chapel Hill / UNC School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center--Myers Park Infectious Disease Clinic Recruiting
Charlotte, North Carolina, United States, 28207
Duke University Recruiting
Durham, North Carolina, United States, 27710
East Carolina University, The Brody School of Medicine Recruiting
Greenville, North Carolina, United States, 27858
Rosedale Infectious Diseases Recruiting
Huntersville, North Carolina, United States, 28078
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Medical University of SC, Division of Infectious Disease Recruiting
Charleston, South Carolina, United States, 29425
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
United States, Texas
Central Texas Clinical Research Recruiting
Austin, Texas, United States, 78705
AIDS ARMS Clinic Recruiting
Dallas, Texas, United States, 75215
North Texas Infectious Diseases Consultants Recruiting
Dallas, Texas, United States, 75246
Therapeutic Concepts, PA Recruiting
Houston, Texas, United States, 77004
Gordon E. Crofoot MD PA Recruiting
Houston, Texas, United States, 77098
Research Access Network Recruiting
Houston, Texas, United States, 77098
Diagnostic Clinic of Longview - Center for Clinical Research Recruiting
Longview, Texas, United States, 75605
United States, Washington
Peter Shalit, MD Recruiting
Seattle, Washington, United States, 98104
Premier Clinical Research Recruiting
Spokane, Washington, United States, 99204
Austria
Medizinische Universitat Wien, Universitätsklinik fur Dermatologie Recruiting
Wien, Austria, 1090
Canada
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Spectrum Health Group Recruiting
Vancouver, British Columbia, Canada, 6Z 2T1
Health Sciences Centre Winnipeg Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Maple Leaf Research Recruiting
Toronto, Ontario, Canada, M5G 1K2
CHU Bichat Recruiting
Montréal, Quebec, Canada, H2L 5B1
McGill University Recruiting
Montréal, Quebec, Canada, H4A 3J1
Clinique de Medeciine Urbaine du Quartier Latin Recruiting
Montréal, Canada, H2L 5B1
France
Hopital Saint-Andre Recruiting
Bordeaux, France, 33075
Hôpital de la Croix Rousse - Maladie Infectieuses et Topicales Recruiting
Lyon, France, 69004
Hôpital Gui de Chauliac, CHU de Montpellier Recruiting
Montpellier, France, 34295
CHU de Nice-l Archet Recruiting
Nice, France, 6202
CHU Bichat Recruiting
Paris, France, 75018
Hôpital Saint Louis - Hopital Saint Antoine - Maladie Infectieuses et Topicales Recruiting
Paris, France, 75475
Hopital Saint Antoine - Maladie Infectieuses et Topicales Recruiting
Paris, France, 75571
AP-HP Hôpital Tenon Recruiting
Paris, France, 75970
Germany
MIB Dienstleistung GmbH Recruiting
Berlin, Germany, 10439
Epimed GmbH Recruiting
Berlin, Germany, 12157
University Hospital Bonn Recruiting
Bonn, Germany, 53127
Universitatsklinik Koln Recruiting
Cologne, Germany, 50937
Universitatsklinikum Essen Recruiting
Essen, Germany, 45122
Universitätsklinikum Frankfurt, Medizinische Klinik Recruiting
Frankfurt am Main, Germany, 60590
Universitatsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Puerto Rico
Instituto de Investigacion Cientifica del Sur Recruiting
Ponce, Puerto Rico, 00730
Clinical Research Puerto Rico Inc Recruiting
San Juan, Puerto Rico, 00909-1711
Hope Clinical Research Recruiting
San Juan, Puerto Rico, 00909
University of Puerto Rico School of Medicine Recruiting
San Juan, Puerto Rico, 00935

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT03110380   History of Changes  
Other Study ID Numbers: GS-US-380-4030  
  2017-000308-17  
Study First Received: April 7, 2017  
Last Updated: December 13, 2017  

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

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.