Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
NCT ID: NCT02607930
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
631 participants
INTERVENTIONAL
2015-11-13
2021-07-02
Brief Summary
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Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
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Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
NCT03547908
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT05979311
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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B/F/TAF
B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks.
B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
ABC/DTG/3TC Placebo
Tablets administered orally, once daily
ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks.
ABC/DTG/3TC
600/50/300 milligrams (mg) tablets administered orally, once daily
B/F/TAF Placebo
Tablets administered orally, once daily
Open-label Phase B/F/TAF to B/F/TAF
After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
Open-label Phase ABC/DTG/3TC to B/F/TAF
After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
Interventions
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ABC/DTG/3TC
600/50/300 milligrams (mg) tablets administered orally, once daily
B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
ABC/DTG/3TC Placebo
Tablets administered orally, once daily
B/F/TAF Placebo
Tablets administered orally, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
* Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second \[mL/sec\]) according to the Cockcroft-Gault formula
* Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences
Exclusion Criteria
* Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
* Females who are pregnant (as confirmed by positive serum pregnancy test)
* Females who are breastfeeding
* Chronic Hepatitis B Virus (HBV) infection
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
Ruane Clinical Research Group, Inc.
Los Angeles, California, United States
Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research
Los Angeles, California, United States
Alameda Health System- Highland Hospital
Oakland, California, United States
University of California Davis
Sacramento, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
La Playa Medical Group
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Kaiser Permanente
San Leandro, California, United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Apex Research
Denver, Colorado, United States
Whitman-Walker Institute
Washington D.C., District of Columbia, United States
Providence Hospital - DC
Washington D.C., District of Columbia, United States
Capital Medical Associates
Washington D.C., District of Columbia, United States
Medical Faculty Associates
Washington D.C., District of Columbia, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
AHF Kinder Medical Group
Miami, Florida, United States
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AIDS Healthcare Foundation-Miami Beach
Pensacola, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Atlanta Infectious Disease Group PC
Atlanta, Georgia, United States
Aids Research Consortium of Atlanta Inc
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Kansas City CARE Clinic
Kansas City, Missouri, United States
Southampton Clinical Research Group, Inc.
St Louis, Missouri, United States
Southampton Healthcare Inc
St Louis, Missouri, United States
Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Santa Fe, New Mexico, United States
Upstate Infectious Disease Associates
Albany, New York, United States
Evergreen Health
Buffalo, New York, United States
North Shore University Hospital-(Manhasset)
Manhasset, New York, United States
Bronx Care
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Aids Research Consortium of Atlanta Inc
Chapel Hill, North Carolina, United States
ID Consultants PA
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, United States
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
MetroHealth Research Institute
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina PPDS
Columbia, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
Saint Hope Foundation Inc
Bellaire, Texas, United States
AIDS Arms Inc
Dallas, Texas, United States
UT Southwestern Clinical Trials Office
Dallas, Texas, United States
North Texas Infectious Diseases Consultants PA
Dallas, Texas, United States
Fort Worth, Texas, United States
Therapeutic Concepts
Houston, Texas, United States
Gordon E Crofoot MD PA
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
Diagnostic Clinic of Longview Center For Clinical Research (DCOL)
Longview, Texas, United States
Peter Shalit MD
Seattle, Washington, United States
Multicare Rockwood HIV Critical Care Clinic
Spokane, Washington, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Clinique Medicale L'actuel
Montreal, , Canada
McGill University Health Center
Montreal, , Canada
Clinique OPUS Inc
Montreal, , Canada
Ottawa Hospital
Ottawa, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
Maple Leaf Research
Toronto, , Canada
Spectrum Health Care
Vancouver, , Canada
Winnipeg Regional Health Authority
Winnipeg, , Canada
Instituto Dominicano de Estudios Virologicos IDEV
Santo Domingo, , Dominican Republic
Hôpital de La Croix Rousse
Lyon, , France
CHU de Nice Archet I
Nice, , France
Paris, , France
Hôpital Saint Louis
Paris, , France
Hôpital Saint Antoine
Paris, , France
Groupe Hospitalier Bichat Claude Bernard
Tourcoing, , France
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
ICH Study Center
Hamburg, , Germany
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, , Italy
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Roma, , Italy
Hope Clinical Research
San Juan, , Puerto Rico
University of Puerto Rico
San Juan, , Puerto Rico
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario de Bellvitge
Badalona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, , Spain
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Chelsea and Westminster NHS Trust
London, , United Kingdom
Mortimer Market Centre
London, , United Kingdom
North Manchester General Hospital - PPDS
Manchester, , United Kingdom
Countries
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References
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Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.
Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.
Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.
Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in art-naïve participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.
Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.
White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.
Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.
Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.
Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.
Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age ≥50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.
Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged ≥ 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual.
Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom.
Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.
Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115.
Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.
Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naïve Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.
Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.
Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual.
Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG + F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29-October 3; Virtual.
Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG + F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.
Sax PE, Hindman JT, Martin H, Wohl D. Two 5-year studies of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: a plain-language summary. Future Microbiol. 2024;19(14):1185-1193. doi: 10.1080/17460913.2024.2372231. Epub 2024 Sep 4.
Orkin C, Antinori A, Rockstroh JK, Moreno-Guillen S, Martorell CT, Molina JM, Lazzarin A, Maggiolo F, Yazdanpanah Y, Andreatta K, Huang H, Hindman JT, Martin H, Pozniak A. Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy. AIDS. 2024 Jun 1;38(7):983-991. doi: 10.1097/QAD.0000000000003865. Epub 2024 Feb 21.
Sax PE, Arribas JR, Orkin C, Lazzarin A, Pozniak A, DeJesus E, Maggiolo F, Stellbrink HJ, Yazdanpanah Y, Acosta R, Huang H, Hindman JT, Martin H, Baeten JM, Wohl D; GS-US-380-1489 and GS-US-380-1490 study investigators. Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. EClinicalMedicine. 2023 May 11;59:101991. doi: 10.1016/j.eclinm.2023.101991. eCollection 2023 May.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Statistical Analysis Plan: Original
Document Type: Statistical Analysis Plan: Amendment 1
Document Type: Statistical Analysis Plan: Final Analysis
Other Identifiers
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2015-004024-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-1489
Identifier Type: -
Identifier Source: org_study_id
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