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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004024-54 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B/F/TAF | Experimental | B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks. |
|
| ABC/DTG/3TC | Active Comparator | ABC/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 | Experimental | 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. |
|
| Open-label Phase ABC/DTG/3TC to B/F/TAF | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC/DTG/3TC | Drug | 600/50/300 milligrams (mg) tablets administered orally, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-2050 | United States | ||
| Spectrum Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29956087 | Result | 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. | |
| 31068270 |
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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/
18 months after study completion
A secured external environment with username, password, and RSA code.
739 participants were screened.
Participants were enrolled at study centers in Europe, Dominican Republic, and North America. The first participant was screened on 13 November 2015. The last study visit occurred on 02 July 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | B/F/TAF | Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) placebo orally once daily for at least 144 weeks, without regard to food. |
| FG001 | ABC/DTG/3TC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blinded Treatment Phase |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Oct 21, 2015 | Jul 25, 2018 |
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| B/F/TAF | Drug | 50/200/25 mg tablets administered orally, once daily, without regard to food |
|
|
| ABC/DTG/3TC Placebo | Drug | Tablets administered orally, once daily |
|
| B/F/TAF Placebo | Drug | Tablets administered orally, once daily |
|
| 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 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 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 144 |
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 20 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 |
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 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 96 |
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 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 144 |
| Change From Baseline in log10 HIV-1 RNA at Week 48 | Baseline, Week 48 |
| Change From Baseline in log10 HIV-1 RNA at Week 96 | Baseline, Week 96 |
| Change From Baseline in log10 HIV-1 RNA at Week 144 | Baseline, Week 144 |
| Change From Baseline in CD4+ Cell Count at Week 48 | Baseline, Week 48 |
| Change From Baseline in CD4+ Cell Count at Week 96 | Baseline, Week 96 |
| Change From Baseline in CD4+ Cell Count at Week 144 | Baseline, Week 144 |
| Percentage Change From Baseline in Hip BMD at Week 48 | Baseline, Week 48 |
| Percentage Change From Baseline in Hip BMD at Week 96 | Baseline, Week 96 |
| Percentage Change From Baseline in Hip BMD at Week 144 | Baseline, Week 144 |
| Percentage Change From Baseline in Spine BMD at Week 48 | Baseline, Week 48 |
| Percentage Change From Baseline in Spine BMD at Week 96 | Baseline, Week 96 |
| Percentage Change From Baseline in Spine BMD at Week 144 | Baseline, Week 144 |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. | Baseline, open-label Week 48 |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. | Baseline, open-label Week 48 |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. | Baseline, open-label Week 96 |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. | Baseline, open-label Week 96 |
| Change From Baseline in CD4+ Cell Count at Week 48 Open-Label | Baseline, open-label Week 48 |
| Change From Baseline in CD4+ Cell Count at Week 96 Open-Label | Baseline, open-label Week 96 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Result |
| 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. |
| 30803969 | Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| 28867497 | Result | 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. |
| 32504574 | Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| 33880558 | Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| Result | 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. |
| 40197415 | Derived | Daar ES, Orkin C, Sax PE, Hagins D, Pozniak A, Workowski K, Brinson C, Tiraboschi JM, Liu H, Deaton C, Cohen C, Madera S, Hindman JT, Ramgopal M. Long-term metabolic changes with bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir-containing regimens for HIV. AIDS Res Ther. 2025 Apr 7;22(1):45. doi: 10.1186/s12981-025-00732-w. |
| 39229805 | Derived | 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. |
| 38349226 | Derived | 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. |
| 37200995 | Derived | 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. |
Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for 144 weeks, without regard to food. |
| FG002 | B/F/TAF to B/F/TAF | After Week 144, participants continued 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 were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. |
| FG003 | ABC/DTG/3TC to B/F/TAF | After Week 144, participants continued 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 were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label B/F/TAF Extension Phase |
|
|
Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | B/F/TAF | Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food Open-Label Extension Phase: 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. |
| BG001 | ABC/DTG/3TC | Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food Open-Label Extension Phase: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Not Permitted = Local regulators did not allow collection of race. | Count of Participants | Participants | No |
| ||||||||||||||
| Race/Ethnicity, Customized | Not Permitted = Local regulators did not allow collection of ethnicity. | Count of Participants | Participants | No |
| ||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| HIV-1 RNA | Mean | Standard Deviation | log10 copies/mL |
| |||||||||||||||
| HIV-1 RNA Categories | Count of Participants | Participants | No |
| |||||||||||||||
| CD4 Cell Count | Mean | Standard Deviation | Cells/µL |
| |||||||||||||||
| CD4 Cell Count Categories | Count of Participants | Participants | No |
| |||||||||||||||
| Hip Bone Mineral Density (BMD) | The Hip Dual-energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD. | Mean | Standard Deviation | g/cm^2 |
| ||||||||||||||
| Spine BMD | The Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing values for baseline spine BMD. | Mean | Standard Deviation | g/cm^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 48 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 20 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in log10 HIV-1 RNA at Week 48 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in log10 HIV-1 RNA at Week 96 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in log10 HIV-1 RNA at Week 144 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline, Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 96 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline, Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 144 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline, Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Hip BMD at Week 48 | Participants in the Hip DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Hip BMD at Week 96 | Participants in the Hip DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Hip BMD at Week 144 | Participants in the Hip DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Spine BMD at Week 48 | Participants in the Spine DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Spine BMD at Week 96 | Participants in the Spine DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Spine BMD at Week 144 | Participants in the Spine DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. | Participants in All B/F/TAF Analysis Set (who were randomized into the randomized phase of the study and received at least 1 dose of the B/F/TAF in the randomized phase or at least 1 dose of the B/F/TAF in the open label extension phase) with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, open-label Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. | Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Failure analysis, it included all participants from the Randomized Phase. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, open-label Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. | Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, open-label Week 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. | Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Failure analysis, it included all participants from the Randomized Phase. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, open-label Week 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 Open-Label | Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase. | Posted | Mean | Standard Deviation | cells/µL | Baseline, open-label Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 96 Open-Label | Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase. | Posted | Mean | Standard Deviation | cell/µL | Baseline, open-label Week 96 |
|
Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B/F/TAF | B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. | 2 | 316 | 44 | 314 | 262 | 314 |
| EG001 | ABC/DTG/3TC | ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food. | 1 | 315 | 54 | 315 | 276 | 315 |
| EG002 | B/F/TAF to B/F/TAF | After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. | 2 | 252 | 19 | 252 | 152 | 252 |
| EG003 | ABC/DTG/3TC to B/F/TAF | After Week 144, participants continued 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 were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. | 2 | 254 | 19 | 254 | 153 | 254 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Middle ear adhesions | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Steatorrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gonococcal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Neurosyphilis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Anticoagulation drug level above therapeutic | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Psychiatric evaluation | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaplastic large-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| High-grade B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Bell's palsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Bipolar I disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Borderline personality disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Delirium tremens | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Drug dependence | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Hallucination, tactile | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Intentional self-injury | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Diabetic nephropathy | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| End stage renal disease | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Endometrial thickening | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Penile necrosis | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Testicular mass | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Alcohol use | Social circumstances | MedDRA 24.0 | Systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| Anal chlamydia infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Chlamydial infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gonorrhoea | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Proctitis gonococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Syphilis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Feb 19, 2016 | Jul 25, 2018 | Prot_005.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Oct 19, 2016 | Jul 25, 2018 | Prot_006.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | May 6, 2019 | Jul 1, 2019 | Prot_008.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Original | May 10, 2017 | Jul 25, 2018 | SAP_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Amendment 1 | May 13, 2019 | Apr 6, 2020 | SAP_009.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Final Analysis | Sep 22, 2021 | Dec 16, 2021 | SAP_010.pdf |
| ID | Term |
|---|---|
| C000631408 | abacavir, dolutegravir, and lamivudine drug combination |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
Not provided
Not provided
Not provided
| Withdrew consent |
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| Investigator's discretion |
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| Adverse Event |
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| Lack of Efficacy |
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| Protocol Violation |
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| Death |
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| Non-compliance with study drug |
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| Belgium |
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| United States |
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| Dominican Republic |
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| Italy |
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| United Kingdom |
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| France |
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| Germany |
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| Spain |
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| Cochran-Mantel-Haenszel | p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US). | 0.78 | Superiority |
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| OG001 | ABC/DTG/3TC to B/F/TAF | Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. |
|
|
| OG001 | ABC/DTG/3TC to B/F/TAF | Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. |
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| OG001 | ABC/DTG/3TC to B/F/TAF | Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. |
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| OG001 | ABC/DTG/3TC to B/F/TAF | Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were 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 was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. |
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