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

NCT03110380 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: GS-US-380-40302017-000308-17
• Study Type: interventional
• Target: 567
• Locations: 6 countries
• Sites: 94

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

  The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines 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 48

Secondary Outcomes (2)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

  Week 48

• Change From Baseline in CD4+ Cell Count at Week 48

  Baseline; Week 48

Study Arms (4)

B/F/TAF

EXPERIMENTAL

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks.

Drug: B/F/TAF; Drug: DTG Placebo; Drug: F/TAF Placebo

DTG + F/TAF

ACTIVE COMPARATOR

DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.

Drug: F/TAF; Drug: DTG; Drug: B/F/TAF Placebo

Open-label Phase B/F/TAF from B/F/TAF

EXPERIMENTAL

Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Drug: B/F/TAF

Open-label Phase B/F/TAF from DTG + F/TAF

EXPERIMENTAL

Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

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

Also known as: GS-9883/F/TAF, Biktarvy®

B/F/TAF; Open-label Phase B/F/TAF from B/F/TAF; Open-label Phase B/F/TAF from DTG + F/TAF

F/TAF DRUG

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

Also known as: Descovy®

DTG + F/TAF

DTG DRUG

50 mg tablet(s) administered orally once daily

Also known as: Tivicay®

DTG + F/TAF

DTG Placebo DRUG

Tablet(s) administered orally once daily

B/F/TAF

F/TAF Placebo DRUG

Tablet(s) administered orally once daily

B/F/TAF

B/F/TAF Placebo DRUG

Tablet(s) administered orally once daily

DTG + F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (94)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

Ruane Clinical Research Group Inc.

Los Angeles, California, 90036, United States

Location

Mills Clinical Research

Los Angeles, California, 90069, United States

Location

Highland Hospital - Alameda Health System

Oakland, California, 94602, United States

Location

Cares Community Health

Sacramento, California, 95814, United States

Location

Kaiser Permanente

Sacramento, California, 95825, United States

Location

Hepatitis/HIV Clinical Trials Group (HHCTG)

San Francisco, California, 94110, United States

Location

Kaiser Permanente

San Francisco, California, 94118, United States

Location

Kaiser Permanente, Department of Infectious Diseases

San Leandro, California, 94577, United States

Location

University of Colorado Denver, University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Whitman-Walker Institute

Washington D.C., District of Columbia, 20005, United States

Location

Dupont Circle Physician's Group

Washington D.C., District of Columbia, 20009, United States

Location

Providence Hospital Center for Infectious Diseases

Washington D.C., District of Columbia, 20017, United States

Location

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

Therafirst Medical Center

Fort Lauderdale, Florida, 33308, United States

Location

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

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

University of Miami Divison of Infectious Diseases Clinical Research Unit

Miami, Florida, 33136, United States

Location

AIDS Healthcare Foundation - South Beach

Miami Beach, Florida, 33140, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

AHF-Pensacola

Pensacola, Florida, 32503, United States

Location

Infectious Disease Research Institute Inc

Tampa, Florida, 33614, United States

Location

St. Joseph's Hospital Comprehensive Research Institute

Tampa, Florida, 33614, United States

Location

AIDS Research and Treatment Center of the Treasure Coast

Vero Beach, Florida, 32960, United States

Location

Triple O Research Institute, P.A.

West Palm Beach, Florida, 33407, United States

Location

Emory Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, 30308, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30312, United States

Location

AU Medical Center

Augusta, Georgia, 30912, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Mercer University, Department of Internal Medicine

Macon, Georgia, 31201, United States

Location

Chatham County Health Department

Savannah, Georgia, 31401, United States

Location

John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako

Honolulu, Hawaii, 96813, United States

Location

University of Louisville 550 Clinic

Louisville, Kentucky, 40202, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Community Research Initiative of New England

Boston, Massachusetts, 02129, United States

Location

Metro West Medical Center

Framingham, Massachusetts, 01702, United States

Location

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

Springfield, Massachusetts, 01105, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

Abbott Northwestern Hospital part of Allina Health

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center, Positive Care Clinic

Minneapolis, Minnesota, 55415, United States

Location

Kansas City CARE Clinic

Kansas City, Missouri, 64111, United States

Location

Southampton Healthcare, Inc.

St Louis, Missouri, 63139, United States

Location

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

Newark, New Jersey, 07102, United States

Location

Southwest CARE Center

Albuquerque, New Mexico, 87109, United States

Location

Southwest CARE Center

Santa Fe, New Mexico, 87505, United States

Location

North Shore University Hospital/Division of Infectious Diseases

Manhasset, New York, 11030, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

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

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Heath System

Durham, North Carolina, 27710, United States

Location

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

Greenville, North Carolina, 27834, United States

Location

Rosedale Infectious Diseases

Huntersville, North Carolina, 28078, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Palmetto Health Richland (Regulatory and Study Supply Shipping)

Columbia, South Carolina, 29203, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

AIDS Arms Inc/ Trinity Health and Wellness Center

Dallas, Texas, 75208, United States

Location

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, 75246, United States

Location

Therapeutic Concepts, PA

Houston, Texas, 77004, United States

Location

Research Access Network

Houston, Texas, 77098, United States

Location

The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)

Houston, Texas, 77098, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Peter Shalit, M.D.

Seattle, Washington, 98104, United States

Location

MultiCare Rockwood HIV Critical Care Clinic

Spokane, Washington, 99204, United States

Location

Medizinische Universitat Wien, Universitatsklinik fur Dermatologie

Vienna, 1090, Austria

Location

Kaye Edmonton Clinic

Edmonton, Alberta, T6G 2G3, Canada

Location

Spectrum Health Clinic

Vancouver, British Columbia, 6Z 2T1, Canada

Location

Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Maple Leaf Research / Maple Leaf Medical Clinic

Toronto, Ontario, M5G 1K2, Canada

Location

Clinique de Médecine Urbaine du Quartier Latin

Montreal, Quebec, H2L 5B1, Canada

Location

Chronical Viral Illness Service/McGill University Health Care (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

Hôpital Saint-André

Bordeaux, 33075, France

Location

Hôpital Croix-Rousse

Lyon, 69004, France

Location

Hôpital Gui de Chauliac, CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nice-l'Archet

Nice, 06202, France

Location

CHU Bichat

Paris, 75018, France

Location

AP-HP Hôpital Tenon

Paris, 75020, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

Hôpital Saint-Antoine

Paris, 75571, France

Location

zibp Zentrum für Infektiologie Berlin Prenzlauer Berg

Berlin, 10439, Germany

Location

EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH

Berlin, 12157, Germany

Location

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie

Bonn, 53127, Germany

Location

Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I

Cologne, 50937, Germany

Location

Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz

Essen, 45122, Germany

Location

Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68

Frankfurt am Main, 60590, Germany

Location

Infektiologikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

ICH Study Center GmbH & Co. KG

Hamburg, 20146, Germany

Location

Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie

Hamburg, 20246, Germany

Location

Instituto de Investigacion Cientifica del Sur

Ponce, 00730, Puerto Rico

Location

Hope Clinical Research

San Juan, 00909, Puerto Rico

Location

Proyecto ACTU

San Juan, 00935, Puerto Rico

Location

Clinical Research Puerto Rico

San Juan, 909, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 32668455 RESULT

• 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.

  PMID: 32701823 RESULT

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; emtricitabine tenofovir alafenamide; dolutegravir

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: June 12, 2017
• Primary Completion: December 4, 2018
• Study Completion: February 10, 2021
• Last Updated: January 11, 2022
• Results First Posted: November 20, 2019

Record last verified: 2021-12

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.

Locations

AU (1); CA (6); US (66); PR (4); FR (8); DE (9)