Clinical trial NCT03110380: Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1-infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (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.


Eligibility 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 ribonucleic acid (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.

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
timeFrame: Week 48
measure: Change From Baseline in CD4+ Cell Count at Week 48
timeFrame: Baseline; Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Spectrum Medical Group
state: Arizona
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group Inc.
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research
state: California
city: Oakland
country: United States
facility: Highland Hospital - Alameda Health System
state: California
city: Sacramento
country: United States
facility: Cares Community Health
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Hepatitis/HIV Clinical Trials Group (HHCTG)
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente, Department of Infectious Diseases
state: California
city: Aurora
country: United States
facility: University of Colorado Denver, University of Colorado Hospital
state: Colorado
city: Washington
country: United States
facility: Whitman-Walker Institute
state: District of Columbia
city: Washington
country: United States
facility: Dupont Circle Physician's Group
state: District of Columbia
city: Washington
country: United States
facility: Providence Hospital Center for Infectious Diseases
state: District of Columbia
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary J. Richmond, M.D., P.A.
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: Miami Beach
country: United States
facility: AIDS Healthcare Foundation - South Beach
state: Florida
city: Miami
country: United States
facility: University of Miami Divison of Infectious Diseases Clinical Research Unit
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Pensacola
country: United States
facility: AHF-Pensacola
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital Comprehensive Research Institute
state: Florida
city: Vero Beach
country: United States
facility: AIDS Research and Treatment Center of the Treasure Coast
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A.
state: Florida
city: Atlanta
country: United States
facility: Emory Hospital Midtown Infectious Disease Clinic
state: Georgia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Augusta
country: United States
facility: AU Medical Center
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Macon
country: United States
facility: Mercer University, Department of Internal Medicine
state: Georgia
city: Savannah
country: United States
facility: Chatham County Health Department
state: Georgia
city: Honolulu
country: United States
facility: John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako
state: Hawaii
city: Louisville
country: United States
facility: University of Louisville 550 Clinic
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Framingham
country: United States
facility: Metro West Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Claudia T Martorell, MD., LLC d/b/a The Research Institute
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital part of Allina Health
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center, Positive Care Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City CARE Clinic
state: Missouri
city: Saint Louis
country: United States
facility: Southampton Healthcare, Inc.
state: Missouri
city: Newark
country: United States
facility: Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Southwest CARE Center
state: New Mexico
city: Santa Fe
country: United States
facility: Southwest CARE Center
state: New Mexico
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital/Division of Infectious Diseases
state: New York
city: Chapel Hill
country: United States
facility: NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Heath System
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care
state: North Carolina
city: Huntersville
country: United States
facility: Rosedale Infectious Diseases
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Health Richland (Regulatory and Study Supply Shipping)
state: South Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: AIDS Arms Inc/ Trinity Health and Wellness Center
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, PA
state: Texas
city: Houston
country: United States
facility: Research Access Network
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Seattle
country: United States
facility: Peter Shalit, M.D.
state: Washington
city: Spokane
country: United States
facility: MultiCare Rockwood HIV Critical Care Clinic
state: Washington
city: Wien
country: Austria
facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie
city: Edmonton
country: Canada
facility: Kaye Edmonton Clinic
state: Alberta
city: Vancouver
country: Canada
facility: Spectrum Health Clinic
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
state: Manitoba
city: Toronto
country: Canada
facility: Maple Leaf Research / Maple Leaf Medical Clinic
state: Ontario
city: Montréal
country: Canada
facility: Clinique de Médecine Urbaine du Quartier Latin
state: Quebec
city: Montréal
country: Canada
facility: Chronical Viral Illness Service/McGill University Health Care (MUHC)
state: Quebec
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Lyon
country: France
facility: Hôpital Croix-Rousse
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac, CHU de Montpellier
city: Nice
country: France
facility: CHU de Nice-l'Archet
city: Paris
country: France
facility: CHU Bichat
city: Paris
country: France
facility: AP-HP Hôpital Tenon
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Berlin
country: Germany
facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
city: Berlin
country: Germany
facility: EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie
city: Cologne
country: Germany
facility: Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I
city: Essen
country: Germany
facility: Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68
city: Frankfurt am Main
country: Germany
facility: Infektiologikum Frankfurt
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co. KG
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie
city: Ponce
country: Puerto Rico
facility: Instituto de Investigacion Cientifica del Sur
city: San Juan
country: Puerto Rico
facility: Hope Clinical Research
city: San Juan
country: Puerto Rico
facility: Proyecto ACTU
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.
citation: Acosta RK, Willkom M, Andreatta K, Liu H, Martin R, Parvangada A, Martin H, Collins S, White KL. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-existing NRTI Resistance. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):363-371. doi: 10.1097/QAI.0000000000002454.