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
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
2 other identifiers
interventional
631
10 countries
121
Brief Summary
The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2015
Longer than P75 for phase_3
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2015
CompletedStudy Start
First participant enrolled
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2017
CompletedResults Posted
Study results publicly available
July 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2021
CompletedMarch 2, 2022
February 1, 2022
1.5 years
November 10, 2015
May 2, 2018
February 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving 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 (23)
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Week 144
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Week 144
- +18 more secondary outcomes
Study Arms (4)
B/F/TAF
EXPERIMENTALB/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks.
ABC/DTG/3TC
ACTIVE COMPARATORABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks.
Open-label Phase B/F/TAF to B/F/TAF
EXPERIMENTALAfter 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.
Open-label Phase ABC/DTG/3TC to B/F/TAF
EXPERIMENTALAfter 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.
Interventions
600/50/300 milligrams (mg) tablets administered orally, once daily
50/200/25 mg tablets administered orally, once daily, without regard to food
Eligibility Criteria
You may qualify if:
- Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
- 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
You may not qualify if:
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (121)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2050, United States
Spectrum Medical Group
Phoenix, Arizona, 85012, United States
Pueblo Family Physicians
Phoenix, Arizona, 85015, United States
Kaiser Permanente Medical Center
Los Angeles, California, 90027, United States
Ruane Clinical Research Group, Inc.
Los Angeles, California, 90036, United States
Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research
Los Angeles, California, 90069, United States
Alameda Health System- Highland Hospital
Oakland, California, 94602, United States
University of California Davis
Sacramento, California, 95817, United States
Kaiser Permanente Medical Group
Sacramento, California, 95825, United States
La Playa Medical Group
San Diego, California, 92103, United States
Kaiser Permanente
San Francisco, California, 94118, United States
Kaiser Permanente
San Leandro, California, 94577, United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Apex Research
Denver, Colorado, 80209, United States
Whitman-Walker Institute
Washington D.C., District of Columbia, 20009, United States
Providence Hospital - DC
Washington D.C., District of Columbia, 20017, United States
Capital Medical Associates
Washington D.C., District of Columbia, 20036, United States
Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308, United States
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, 33316, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982, United States
AHF Kinder Medical Group
Miami, Florida, 33133, United States
Unknown Facility
Miami, Florida, 33140, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
AIDS Healthcare Foundation-Miami Beach
Pensacola, Florida, 32504, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, 33614, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, 32960, United States
Triple O Research Institute PA
West Palm Beach, Florida, 33401, United States
Emory University
Atlanta, Georgia, 30308, United States
Atlanta Infectious Disease Group PC
Atlanta, Georgia, 30309, United States
Aids Research Consortium of Atlanta Inc
Atlanta, Georgia, 30312, United States
Augusta University
Augusta, Georgia, 30912, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Chatham County Health Department
Savannah, Georgia, 31401, United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, 46202, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Kansas City CARE Clinic
Kansas City, Missouri, 64111, United States
Southampton Clinical Research Group, Inc.
St Louis, Missouri, 63108, United States
Southampton Healthcare Inc
St Louis, Missouri, 63139, United States
Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center
Newark, New Jersey, 07102, United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244, United States
Unknown Facility
Santa Fe, New Mexico, 87505, United States
Upstate Infectious Disease Associates
Albany, New York, 12208, United States
Evergreen Health
Buffalo, New York, 14215, United States
North Shore University Hospital-(Manhasset)
Manhasset, New York, 11030, United States
Bronx Care
The Bronx, New York, 10457, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Aids Research Consortium of Atlanta Inc
Chapel Hill, North Carolina, 27514, United States
ID Consultants PA
Charlotte, North Carolina, 28209, United States
Unknown Facility
Greensboro, North Carolina, 27401, United States
East Carolina University
Greenville, North Carolina, 27858-4354, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, 27157-1042, United States
Summa Health System
Akron, Ohio, 44304, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
MetroHealth Research Institute
Cleveland, Ohio, 44109, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Medical University of South Carolina PPDS
Columbia, South Carolina, 29203-6840, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Saint Hope Foundation Inc
Bellaire, Texas, 77401, United States
AIDS Arms Inc
Dallas, Texas, 75215, United States
UT Southwestern Clinical Trials Office
Dallas, Texas, 75235, United States
North Texas Infectious Diseases Consultants PA
Dallas, Texas, 75246, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Therapeutic Concepts
Houston, Texas, 77004, United States
Gordon E Crofoot MD PA
Houston, Texas, 77098, United States
Research Access Network
Houston, Texas, 77098, United States
Diagnostic Clinic of Longview Center For Clinical Research (DCOL)
Longview, Texas, 75605, United States
Peter Shalit MD
Seattle, Washington, 98104, United States
Multicare Rockwood HIV Critical Care Clinic
Spokane, Washington, 99204, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226, United States
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Gent
Ghent, B-9000, Belgium
Clinique Medicale L'actuel
Montreal, H2L 5B1, Canada
McGill University Health Center
Montreal, H2X 2P4, Canada
Clinique OPUS Inc
Montreal, H3A 1T1, Canada
Ottawa Hospital
Ottawa, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, M4N 3M5, Canada
Maple Leaf Research
Toronto, M5G 1K2, Canada
Spectrum Health Care
Vancouver, V6Z 2T1, Canada
Winnipeg Regional Health Authority
Winnipeg, R3A 1R9, Canada
Instituto Dominicano de Estudios Virologicos IDEV
Santo Domingo, 10103, Dominican Republic
Hôpital de La Croix Rousse
Lyon, 69317, France
CHU de Nice Archet I
Nice, 06200, France
Unknown Facility
Paris, 75018, France
Hôpital Saint Louis
Paris, 75475, France
Hôpital Saint Antoine
Paris, 75571, France
Groupe Hospitalier Bichat Claude Bernard
Tourcoing, 59208, France
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
ICH Study Center
Hamburg, 20146, Germany
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, 20127, Italy
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Roma, Italy
Hope Clinical Research
San Juan, 00909, Puerto Rico
University of Puerto Rico
San Juan, 00935, Puerto Rico
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital General Universitario de Alicante
Alicante, 3010, Spain
Hospital Universitario de Bellvitge
Badalona, 08907, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, 36312, Spain
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B4 6DH, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 3EW, United Kingdom
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London, E1 1BB, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
Kings College Hospital
London, SE5 9RJ, United Kingdom
Chelsea and Westminster NHS Trust
London, SW10 9TH, United Kingdom
Mortimer Market Centre
London, WC1E 6JB, United Kingdom
North Manchester General Hospital - PPDS
Manchester, M8 5RB, United Kingdom
Related Publications (23)
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.
PMID: 29956087RESULTWohl 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.
PMID: 31068270RESULTAcosta 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.
PMID: 30803969RESULTAcosta 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.
RESULTAcosta 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.
RESULTWhite 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.
RESULTGallant 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.
PMID: 28867497RESULTOrkin 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.
PMID: 32504574RESULTAcosta 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.
RESULTMills 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.
RESULTRamgopal 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.
RESULTAcosta 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.
RESULTWorkowski 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.
RESULTAcosta 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.
PMID: 33880558RESULTArribas 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.
RESULTAcosta 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.
RESULTAcosta 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.
RESULTAcosta 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.
RESULTDaar 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.
RESULTPozniak 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.
RESULTSax 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.
PMID: 39229805DERIVEDOrkin 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.
PMID: 38349226DERIVEDSax 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.
PMID: 37200995DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
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
November 10, 2015
First Posted
November 18, 2015
Study Start
November 13, 2015
Primary Completion
May 9, 2017
Study Completion
July 2, 2021
Last Updated
March 2, 2022
Results First Posted
July 23, 2018
Record last verified: 2022-02
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.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/