Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005114-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E/C/F/TAF | Experimental | Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. |
|
| Stay on Baseline Treatment Regimen (SBR) | Active Comparator | Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E/C/F/TAF | Drug | 150/150/200/10 mg FDC tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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 |
|---|---|---|
| Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented. | Baseline; Week 48 |
| Percent Change From Baseline in Spine BMD at Week 48 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | United States | ||
| Southwest Center for HIV/AIDS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26538525 | Result | Mills A, Arribas JR, Andrade-Villanueva J, DiPerri G, Van Lunzen J, Koenig E, Elion R, Cavassini M, Madruga JV, Brunetta J, Shamblaw D, DeJesus E, Orkin C, Wohl DA, Brar I, Stephens JL, Girard PM, Huhn G, Plummer A, Liu YP, Cheng AK, McCallister S; GS-US-292-0109 team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016 Jan;16(1):43-52. doi: 10.1016/S1473-3099(15)00348-5. Epub 2015 Nov 2. | |
| 28259777 |
Not provided
Not provided
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
18 months after study completion
A secured external environment with username, password, and RSA code.
1559 participants were screened.
Participants were enrolled at study sites in Dominican Republic, Puerto Rico, North America, South America, Europe, Australia, and Asia. The first participant was screened on 27 March 2013. The last study visit occurred on 01 April 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | E/C/F/TAF | Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Treatment Phase-Up to Week 96 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| E/C/F/TDF | Drug | 150/150/200/300 mg FDC tablet administered orally once daily |
|
|
| EFV/FTC/TDF | Drug | 600/200/300 mg FDC tablet administered orally once daily |
|
|
| RTV | Drug | 100 mg tablet administered orally once daily |
|
|
| ATV | Drug | 300 mg capsule administered orally once daily |
|
|
| FTC/TDF | Drug | 200/300 mg tablet administered orally once daily |
|
|
| COBI | Drug | 150 mg tablet administered orally once daily |
|
|
Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented. |
| Baseline; Week 48 |
| Change From Baseline in Serum Creatinine at Week 48 | Baseline; Week 48 |
| Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit. | Baseline; Week 48 |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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 With HIV-1 RNA < 20 Copies/mL at Week 48 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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 With HIV-1 RNA < 20 Copies/mL at Week 96 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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 |
| Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. | Baseline; Week 48 |
| Change From Baseline in CD4 Cell Count at Weeks 96 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. | Baseline; Week 96 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Spectrum Medical Group | Phoenix | Arizona | 85012 | United States |
| Health for Life Clinic PLLC | Little Rock | Arkansas | 72207 | United States |
| AHF Research Center | Beverly Hills | California | 90211 | United States |
| Michael Keith Wensley, MD, Inc., A Medical Corporation | Costa Mesa | California | 92626 | United States |
| Living Hope Clinical Foundation | Long Beach | California | 90813 | United States |
| Kaiser Permanente | Los Angeles | California | 90027 | United States |
| Jeffrey Goodman Special Care Clinic | Los Angeles | California | 90028 | United States |
| Peter J Ruane, MD, Inc | Los Angeles | California | 90036 | United States |
| Anthony Mills MD Inc | Los Angeles | California | 90069 | United States |
| Orange Coast Medical Group | Newport Beach | California | 92663 | United States |
| Alameda County Medical Center | Oakland | California | 94602 | United States |
| East Bay AIDS Center | Oakland | California | 94609 | United States |
| Stanford University | Palo Alto | California | 94303 | United States |
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | United States |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | United States |
| Metropolis Medical Group | San Francisco | California | 94109 | United States |
| Kaiser Permanente Medical Center, Clinical Trials Unit | San Francisco | California | 94118 | United States |
| Kaiser Permanente Hospital | San Leandro | California | 94577 | United States |
| Apex Research LLC | Denver | Colorado | 80209 | United States |
| Greenwich Hospital | Greenwich | Connecticut | 06830 | United States |
| Yale University HIV Clinical Trials Program | New Haven | Connecticut | 06510 | United States |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | United States |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States |
| Capital Medical Associates, PC | Washington D.C. | District of Columbia | 20036 | United States |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | United States |
| Broward Health/Comprehensive Care Center | Fort Lauderdale | Florida | 33311 | 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 |
| The Kinder Medical Group | Miami | Florida | 33133 | United States |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| IDOCF/ Value Health MD, LLC | Orlando | Florida | 32806 | United States |
| University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department | Tampa | Florida | 33602 | United States |
| Infectious Disease Research Institute Inc. | Tampa | Florida | 33614 | United States |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33615 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | United States |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | United States |
| Mercer University School of Medicine | Macon | Georgia | 31201 | United States |
| University of Hawaii - Hawaii Center for AIDS | Honolulu | Hawaii | 96816 | United States |
| Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | United States |
| Howard Brown Health Center | Chicago | Illinois | 60613 | United States |
| NorthStar Medical Center | Chicago | Illinois | 60657 | United States |
| Community Research Initiative of New England | Boston | Massachusetts | 02111 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Baystate Infectious Diseases Clinical Research | 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 |
| Central West Clinical Research | St Louis | Missouri | 63108 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| Southampton Healthcare | St Louis | Missouri | 63139 | United States |
| ID Care | Hillsborough | New Jersey | 08844 | United States |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | United States |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | United States |
| SouthWest CARE Center | Santa Fe | New Mexico | 87505 | United States |
| Upstate ID Association | Albany | New York | 12208 | United States |
| Albany Medical College | Albany | New York | 12209 | United States |
| New York Hospital Queens | Flushing | New York | 11355 | United States |
| North Shore University Hospital, Divison of Infectious Diseases | Manhasset | New York | 11030 | United States |
| Greiger Clinic | Mount Vernon | New York | 10550 | United States |
| Beth Israel Medical Center- Division of Infectious Diseases | New York | New York | 10003 | United States |
| Chelsea Village Medical, PC | New York | New York | 10011 | United States |
| Ricky K. Hsu, MD | New York | New York | 10011 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - AIDS Center | The Bronx | New York | 10467 | United States |
| University of NC AIDS Clinical Trials Unit | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center-Myers Park | Charlotte | North Carolina | 28207 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | United States |
| AIDS Arms, Inc./ Peabody Health Center | Dallas | Texas | 75215 | United States |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75219 | United States |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| Garcia's Family Health Group | Harlingen | Texas | 78550 | United States |
| Therapeutic Concepts, P.A. | Houston | Texas | 77004 | United States |
| Gordon E. Crofoot MD PA | Houston | Texas | 77098 | United States |
| Research Access Network | Houston | Texas | 77098 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID) | Annandale | Virginia | 22003 | United States |
| Peter Shalit, M.D. | Seattle | Washington | 98104 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| East Sydney Doctors | Darlinghurst | New South Wales | 2010 | Australia |
| Holdsworth House Medical practice | Darlinghurst | New South Wales | 2010 | Australia |
| St Vincent's Hospital, Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Taylor Square Private Clinic | Darlinghurst | New South Wales | 2010 | Australia |
| Albion Street Centre | Surry Hills | New South Wales | 2010 | Australia |
| Melbourne Sexual Health Clinic | Carlton | Victoria | 3053 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Northside Clinic | Melbourne | Victoria | 3068 | Australia |
| Prahran Market Clinic | South Yarra | Victoria | 3141 | Australia |
| Medizinische Universität Graz | Graz | 8020 | Austria |
| Medizinische Universitat Wien | Vienna | 1090 | Austria |
| SMZ Baumgartner Hoehe - Otto-Wagner-Spital | Vienna | 1140 | Austria |
| CHU Saint-Pierre University Hospital | Brussels | 1000 | Belgium |
| Hôpital Universitaire Erasme - ULB | Ghent | 1070 | Belgium |
| Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz | Rio de Janeiro | 21040-360 | Brazil |
| Faculdade de Medicina do ABC | Santo André | 09060-650 | Brazil |
| São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas | São Paulo | 01246-900 | Brazil |
| São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS | São Paulo | 04121-000 | Brazil |
| Ubc Downtown I.D. Clinic | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Maple Leaf Research | Toronto | Ontario | M5G 1K2 | Canada |
| University Health Network, Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Clinique medicale l'Actuel | Montreal | Quebec | H2L 4P9 | Canada |
| Clinique Medicale du Quartier Latin | Montreal | Quebec | H2L 5B1 | Canada |
| McGill University Health Centre (MUHC) - Montral Chest Institute | Montreal | Quebec | H2X 2P4 | Canada |
| Clinique OPUS | Montreal | Quebec | H3A 1T1 | Canada |
| Epidemiklinikken 5112, Rigshospitalet | Copenhagen | 2100 | Denmark |
| Instituto Dominicano de Estudios Virologicos - IDEV | Santo Domingo | Dominican Republic |
| Hôpital de La Croix Rousse | Lyon | 75970 | France |
| CHU Hotel Dieu | Nantes | 44093 | France |
| Archet 1 CHU de Nice - 6ème Niveau | Nice | 06200 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Bichat Hospital | Paris | 75018 | France |
| Centre Hospitalier de Tourcoing | Tourcoing | 59208 | France |
| EPIMED GmbH | Berlin | 12157 | Germany |
| University of Bonn | Bonn | 53127 | Germany |
| University of Cologne, Department of Internal Medicine | Cologne | 50937 | Germany |
| Center for HIV and Hepatogastroenterology | Düsseldorf | 40237 | Germany |
| Infektio Research GmbH / Infektiologikum Frankfurt | Frankfurt am Main | 60311 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| ICH Study Center Hamburg | Hamburg | 20146 | Germany |
| University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit | Hamburg | 20246 | Germany |
| MUC Research GmbH | München | 80335 | Germany |
| Fondazione Centro San Raffaele del Monte Tabor | Milan | 20127 | Italy |
| Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive | Milan | 20157 | Italy |
| Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS | Rome | 00149 | Italy |
| Comprensorio Amedeo Di Savoia Birago Di Vische | Torino | 10149 | Italy |
| Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" | Guadalajara | 44280 | Mexico |
| Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten | Amsterdam | 1091 AC | Netherlands |
| Erasmus MC | Rotterdam | 3000 CA | Netherlands |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Servico De Doencas Infecciosas - Hospital De Sao Joao | Porto | 4202-451 | Portugal |
| Clinical Research Puerto Rico | San Juan | PR | 00909 | Puerto Rico |
| HOPE Clinical Research | San Juan | Pr | 00909 | Puerto Rico |
| VA Caribbean Healthcare System | San Juan | Pr | 00921 | Puerto Rico |
| Hospital Universitari De Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Södersjukhuset | Stockholm | 11883 | Sweden |
| Universitätsklinik für Infektiologie, Universitätsspital Bern | Bern | 3010 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| University Hospital of Zurich | Zurich | 8091 | Switzerland |
| HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine | Chiang Mai | 50200 | Thailand |
| Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Brighton and Sussex University Hospitals NHS Trust | Brighton | BN2 1ES | United Kingdom |
| Barts and the London NHS Trust | London | E1 1BB | United Kingdom |
| Chelsea and Westminster Hospital Foundation Trust | London | SW10 9NH | United Kingdom |
| Courtyard Clinic, St. Georges Hospital | London | SW17 0QT | United Kingdom |
| North Manchester General Hospital | Manchester | M8 5RB | United Kingdom |
| Result |
| Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2. |
| Result | Brown T, Yin MT, Gupta S, Katlama C, et al. Switching from TDF to TAF in HIV-infected adults with low BMD: a pooled analysis. 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2017; poster presentation: abstract #683. |
| Result | Podzamczer D, Viciana P, Rijnders B, Shalit P, et al. Switching from Tenofovir disoproxil fumarate to tenofovir alafenamide in patients with high risk for chronic kidney disease. 8th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 9th Teacher Meeting of AIDS Research Network 2016; poster presentation: abstract #P-188. |
| Result | Orkin C, Rjinders B, Stephan C, McKellar M, et al. Switching from boosted atazanavir (ATV) plus FTC/TDF to a TAF-based single tablet regimen (STR): Week 48 data in virologically suppressed adults. Annual Conference of the British Association for Sexual Health and HIV (BASHH) 2016; poster presentation: abstract # P045. |
| Result | Mills A, Andrade J, Koenig E, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 13th Congress for Infectious Diseases and Tropical Medicine (KIT) 2016; poster presentation: abstract #eP-038. |
| Result | Overton ET, Shalit P, Crofoot G, Benson P, et al. Switch from TDF regimens to E/C/F/TAF is associated with improved bone mineral density (BMD), decreased serum PTH and decreased bone turnover biomarkers. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract #PW-027. |
| Result | Huhn G, Rijnders B, Thompson M, Tebas P, et al. Switching from TDF to TAF in patients with high risk for CKD. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; oral presentation: https://www.natap.org/2016/HIV/062116_01.htm. |
| Result | Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abstract #496. |
| Result | Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33. |
| Result | Mills A, Andrade J, Di Perri G, Van Lunzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 8th Biennial Conference on HIV Pathogenesis and Treatment and Prevention of the International AIDS Society (IAS) 2015; oral presentation: abstract #TUAB0102. |
| Result | Shamblaw D, Van Lunzen J, Orkin C, Bloch M, eta al. Switching from Atripla (ATR) to a tenofovir alafenamide (TAF)-based single tablet regimen: week 48 data in virologically suppressed adults. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2015; oral presentation; https://natap.org/2015/ICAAC/ICAAC_13.htm. |
| Result | Thompson M, Morales-Ramirez J, Mcdonald C, Rachlis A, et al. Switching from a tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): Week 48 data in HIV-1 infected virologically suppressed adults. Spring Conference of the Society for Healthcare Epidemiology of America (SHEA) 2015; oral presentation: abstract #725. |
| Result | Rijnders B, Stephan C, Lazzarin A, Squires K, et al. Switching from ritonavir or cobicistat boosted atazanavir (ATV) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): week 48 data in virologically suppressed adults. 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #577. |
| Result | Lutz T, Benson P, Goffard J-C, Haubrich R, et al. Patient reported outcomes (PRO) over 48 weeks in a randomized, open-label trial of patients with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF). 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #324. |
| Result | Viciana P, Mills A, Andrade J, Diperri G, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 7th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 8th Teacher Meeting of AIDS Research Network 2015; oral presentation: abstract #PO-08. |
| Result | Mills A, Andrade-Villanueva J, DiPerri G, Van Luzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: Data in virologically suppressed adults through 48 weeks of treatment. 8th Annual International AIDS Society meeting 2015; oral presentation: abstract #839. |
| Result | Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209. |
| Result | Stellbrink H, Gandhi-Patel B, Zhong L, Das M, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #205. |
| Result | Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 15th Congress on Infectious Diseases and Tropical Medicine - German Society for Infectious Diseases (DPID) held jointly with the 29th Annual Meeting of the German Society for Pediatric Infectiology (DGPI) 2020; poster presentation: abstract #A-343. |
| 30932951 | Result | Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223. |
| 31826005 | Result | Hermansson L, Yilmaz A, Price RW, Nilsson S, McCallister S, Makadzange T, Das M, Zetterberg H, Blennow K, Gisslen M. Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate. PLoS One. 2019 Dec 11;14(12):e0226276. doi: 10.1371/journal.pone.0226276. eCollection 2019. |
| Result | Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE9-50. |
| Result | Pepperrell T, Hughes S, Gotham D, Pozniak A, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate - is there a true difference in safety? 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE3-8. |
| Result | Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21. |
| Result | Dejesus E, Federico Andrade Villanueva J, Ramon Arribas Lopez J, Brinson C, et al. Tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in hispanic/latinx and black participants: efficacy, bone and renal safety results from a pooled analysis of 7 clinical trials. IDWeek Meeting of the Infectious Diseases Society of America (IDSA) 2019; poster presentation: abstract #318. |
| Result | Walmsley S, Andany N, Brar I, Brinson C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. 28th Annual Canadian Conference on HIV/AIDS Research - Canadian Association for HIV Research (CAHR) 2019; poster presentation: abstract #CSP9.04. |
| 31303140 | Result | Kim YS, Oka S, Chetchotisakd P, Clarke A, Supparatpinyo K, Avihingsanon A, Ratanasuwan W, Kiertiburanakul S, Ruxrungtham K, Yang S, Guo S, Liu Y, Das M, Tran D, McColl D, Corales R, Nguyen C, Piontkowsky D. Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials. HIV Res Clin Pract. 2019 Jun;20(3):73-81. doi: 10.1080/15284336.2019.1589232. Epub 2019 Jul 8. |
| Result | Hermansson L, Price RW, Yilmaz A, Nilsson S, et al. Effect on plasma NFL, a marker or neuronal injury, after switching from TDF to TAF. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; oral presentation: abstract #127. |
| Result | Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; poster presentation: abstract #519. |
| Result | Orkin C, Castelli F, Yazdanpanah Y, Rockstroh J, et al. Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate. 22nd International AIDS Conference - International AIDS Society 2018; poster presentation: abstract #TUPEB104. |
| Result | Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724. |
| 29368537 | Result | DeJesus E, Haas B, Segal-Maurer S, Ramgopal MN, Mills A, Margot N, Liu YP, Makadzange T, McCallister S. Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment. AIDS Res Hum Retroviruses. 2018 Apr;34(4):337-342. doi: 10.1089/AID.2017.0203. Epub 2018 Mar 20. |
| Result | Goldstein D, Ward D, Brinson C, Crofoot G, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-Infected virologically-suppressed adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A90. |
| Result | Ward D, Thompson M, Goldstein D, Brinson C, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-infected treatment-naïve adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A91. |
| Result | Choe S, Podzamvzer D, Tashima K, McNicholl I, and McCallister S. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) 2017; poster presentation: abstract #7-068. |
| Result | Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021. |
| Result | Podzamczer D, Tashima K, Daar E, McGowan J, et al. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). International Congress of Drug Therapy in HIV Infection - International AIDS Society 2016; poster presentation: abstract #P314. |
| Result | Dejesus E, Haas B, Segal-Maurer S, Ramgopal M, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF) regimen to a tenofovir alafenamide (TAF) based regimen through 96 weeks (W96) of treatment. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract # LB-087. |
| Result | Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070. |
| FG001 | Stay on Baseline Treatment Regimen (SBR) | Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Treatment Phase- After Week 96 |
|
|
Safety Analysis Set included participants who were randomized and received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E/C/F/TAF | Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)(150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. |
| BG001 | Stay on Baseline Treatment Regimen (SBR) | Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HIV-1 RNA Category | Count of Participants | Participants |
|
| 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 With HIV-1 RNA < 50 Copies/mL at Week 48 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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 participants who were randomized and received at least 1 dose of study drug. New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut. | Posted | Number | percentage of participants | Week 48 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented. | Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Spine BMD at Week 48 | Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented. | Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine at Week 48 | Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut | Posted | Mean | Standard Deviation | mg/dL | Baseline; Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit. | Participants in EFV-Related Symptom Analysis Set with available data were analyzed. NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut | Posted | Mean | Standard Deviation | units on a scale | Baseline; Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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 With HIV-1 RNA < 20 Copies/mL at Week 48 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut. | Posted | Number | percentage of participants | Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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 | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. | Participants in the Full Analysis Set with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut. | Posted | Mean | Standard Deviation | cells/uL | Baseline; Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 Cell Count at Weeks 96 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/uL | Baseline; Week 96 |
|
|
From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug.
For All Cause Mortality: All Randomized Analysis Set included all participants who were 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 | Randomized Phase: E/C/F/TAF | Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; EVG/COBI/FTC/TAF; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase. | 4 | 963 | 79 | 959 | 620 | 959 |
| EG001 | Randomized Phase: Stay on Baseline Treatment Regimen (SBR) | Participants stayed on their baseline emtricitabine(FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase. | 0 | 480 | 39 | 477 | 286 | 477 |
| EG002 | Extension Phase: E/C/F/TAF From E/C/F/TAF | After completing 96 weeks of randomized treatment (E/C/F/TAF), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. | 1 | 905 | 27 | 905 | 298 | 905 |
| EG003 | Extension Phase: E/C/F/TAF From SBR | After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. | 1 | 424 | 22 | 424 | 144 | 424 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vascular stent occlusion | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hydrocholecystis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bacterial colitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| H1n1 influenza | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatitis syphilitic | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Neurosyphilis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Perineal infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Reiter's syndrome | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Secondary syphilis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Bone cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Lung adenocarcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (23.0) | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA (23.0) | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fanconi syndrome acquired | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiogenic pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Substance use | Social circumstances | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
There were no limitations affecting the analysis or results.
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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D019438 | Ritonavir |
| D000069446 | Atazanavir Sulfate |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000069547 | Cobicistat |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D010078 | Oxazines |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Withdrew Consent |
|
| Adverse Event |
|
| Death |
|
| Male |
|
| Asian |
|
| Black |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Local regulators did not allow collection of race or ethnicity information |
|
| Other |
|
| Not Hispanic or Latino |
|
| Local regulators did not allow collection of race or ethnicity information |
|
| United Kingdom |
|
| Thailand |
|
| Portugal |
|
| Switzerland |
|
| Spain |
|
| Canada |
|
| Austria |
|
| Netherlands |
|
| Sweden |
|
| Belgium |
|
| Brazil |
|
| Denmark |
|
| Dominican Republic |
|
| Italy |
|
| Mexico |
|
| Australia |
|
| France |
|
| Germany |
|
| ≥ 50 copies/mL |
|
| All Participants |
|
|
Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
| All Participants | Cochran-Mantel-Haenszel | <0.001 | The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen. | Difference in percentages | 4.1 | 2-Sided | 95 | 1.6 | 6.7 | The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen. | Non-Inferiority or Equivalence (legacy) | Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group. |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|