Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004458-27 | 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 efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E/C/F/TAF (Double-Blind Phase) | Experimental | E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks |
|
| E/C/F/TDF (Double-Blind Phase) | Active Comparator | E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks |
|
| Open-Label Extension Phase | Experimental | After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country. |
|
| 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 |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were 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. | Weeks 96 and 144 |
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 |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Spectrum Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25890673 | Result | Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15. | |
| 28282300 |
Not provided
Not provided
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
1105 participants were screened.
Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 26 December 2012. The last study visit occurred on 06 September 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | E/C/F/TAF | Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for at least 144 weeks. Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences terminated the study in that country. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Phase |
|
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 |
|
|
| E/C/F/TDF Placebo | Drug | Tablet administered orally once daily |
|
| E/C/F/TAF Placebo | Drug | Tablet administered orally once daily |
|
| Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were 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. | Weeks 48, 96. and 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 |
| 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. | Baseline; Week 48 |
| Percent Change From Baseline in Hip BMD at Week 96 | Hip BMD was assessed by DXA scan. | Baseline; Week 96 |
| Percent Change From Baseline in Hip BMD at Week 144 | Hip BMD was assessed by DXA scan. | Baseline; Week 144 |
| Percent Change From Baseline in Spine BMD at Week 48 | Spine BMD was assessed by DXA scan. | Baseline; Week 48 |
| Percent Change From Baseline in Spine BMD at Week 96 | Spine BMD was assessed by DXA scan. | Baseline; Week 96 |
| Percent Change From Baseline in Spine BMD at Week 144 | Spine BMD was assessed by DXA scan. | Baseline; Week 144 |
| Change From Baseline in Serum Creatinine at Week 48 | Baseline; Week 48 |
| Change From Baseline in Serum Creatinine at Week 96 | Baseline; Week 96 |
| Change From Baseline in Serum Creatinine at Week 144 | Baseline; Week 144 |
| Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. | Up to 48 weeks |
| Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. | Up to 96 weeks |
| Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. | Up to 144 weeks |
| Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. | Baseline; Week 48 |
| Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. | Baseline; Week 96 |
| Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. | Baseline; Week 144 |
| Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. | Baseline; Week 48 |
| Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. | Baseline; Week 96 |
| Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. | Baseline; Week 144 |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Kaiser Permanente Los Angeles | Los Angeles | California | 90027 | United States |
| University of California, Los Angeles | Los Angeles | California | 90035 | United States |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | United States |
| Anthony Mills MD Inc | Los Angeles | California | 90069 | United States |
| East Bay AIDS Center | Oakland | California | 94609 | United States |
| Kaiser Permanente - Sacramento | Sacramento | California | 95825 | United States |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | United States |
| University of California, San Diego | San Diego | California | 92103 | United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Apex Research, LLC | Denver | Colorado | 80209 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Dupont Circle Physicians Group, P.C. | Washington D.C. | District of Columbia | 20009 | United States |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States |
| Capital Medical Associates, P.C. | Washington D.C. | District of Columbia | 20036 | United States |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | 33316 | United States |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | 34982 | United States |
| The Kinder Medical Group | Miami | Florida | 33133 | United States |
| AIDS Healthcare Foundation | Miami Beach | Florida | 33139 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| IDOCF/ValuHealthMD, LLC | Orlando | Florida | 32806 | United States |
| Infectious Diseases Associates | Pensacola | Florida | 32504 | United States |
| The University of South Florida | Tampa | Florida | 33602 | United States |
| Infectious Disease Research Institute Inc. | Tampa | Florida | 33614 | United States |
| St. Joseph's Comprenhensive Research Inisitute | Tampa | Florida | 33614 | United States |
| AIDS Research and Treatment Center of the Treasure Coast | Vero Beach | Florida | 32960 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | United States |
| Infectious Disease Specialist 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 |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | United States |
| Howard Brown Health Center | Chicago | Illinois | 60613 | United States |
| Institute of Human Virology, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Community Research Initative | Boston | Massachusetts | 02111 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Metrowest Medical Center | Framingham | Massachusetts | 01702 | United States |
| Baystate Infectious Diseases Clinical Research | Springfield | Massachusetts | 01199 | United States |
| Be Well Medical Center | Berkley | Michigan | 48072 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Central West Clinical Research, Inc. | St Louis | Missouri | 63108 | United States |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | United States |
| ID Care | Hillsborough | New Jersey | 08844 | United States |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Upstate Infectious Diseases Associates | Albany | New York | 12208 | United States |
| New York Hospital Queens | Flushing | New York | 11355 | United States |
| North Shore University Hospital - Division of Infectious Diseases | Manhasset | New York | 11030 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Infectious Disease Consultants, PA | Charlotte | North Carolina | 28209 | United States |
| Duke University | Durham | North Carolina | 22710 | United States |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | United States |
| Summa Health Care Center | Akron | Ohio | 44304 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of South Carolina School of Medicine | Columbia | South Carolina | 29203 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| St. Hope Foundation, Inc. | Bellaire | Texas | 77401 | United States |
| Trinity Health and Wellness Center/AIDS Arms, Inc. | Dallas | Texas | 75208 | United States |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | United States |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| Garcias' Family Health Group | Harlingen | Texas | 78550 | United States |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | United States |
| Gordon E. Crofoot, MD, PA | Houston | Texas | 77098 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | 22003 | United States |
| Peter Shalit, MD | Seattle | Washington | 98104 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Holdsworth House Medical Practice | Darlinghurst | New South Wales | 2010 | Australia |
| Taylor Square Private Clinic | Darlington | New South Wales | 2010 | Australia |
| East Sydney Doctors | Sydney | New South Wales | 2010 NSW | Australia |
| Albion Street Centre | Sydney | Southwest | 2010 | Australia |
| Melbourne Sexual Health Clinic | Carlton | Victoria | 3053 | Australia |
| DIAID, Department of Dermatology, Medical University Vienna | Vienna | 1090 | Austria |
| Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe | Vienna | 1140 | Austria |
| Hôpital Erasme-ULB | Anderlecht | Brussels Capital | 1070 | Belgium |
| CHU Saint-Pierre University Hospital | Brussels | 1000 | Belgium |
| Spectrum Health | Vancouver | British Columbia | V6Z 2T1 | Canada |
| Health Sciences Centre Winnipeg | Winnipeg | Manitoba | R3A 1R9 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Maple Leaf Research | Toronto | Ontario | M5G 1K2 | Canada |
| Clinique Medicale Du Quartier Latin | Montreal | Quebec | H2L 5B1 | Canada |
| Clinique medicale l'Actuel | Montreal | Quebec | H2L 5B1 | Canada |
| Clinique OPUS | Montreal | Quebec | H3A 1T1 | Canada |
| Sunnybrook Health Science Center | Toronto | M4N 3M5 | Canada |
| Ospedale San Raffaele | Milan | 20127 | Italy |
| National Center for Global Health and Medicine AIDS Clinical Center | Shinjuku-ku, Tokyo | 162-8655 | Japan |
| HOPE Clinical Research | San Juan | 00909 | Puerto Rico |
| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| University Hospital Bellvitge | Barcelona | 08907 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) | Santiago de Compostela | 15706 | Spain |
| Universitätsspital Bern | Bern | 3010 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| University Hospital, Zurich | Zurich | CH-8091 | Switzerland |
| The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT) | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Chiang Mai University | Chiang Mai | 50200 | Thailand |
| Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Bamrasnaradura Infectious Diseases Institute | Nonthaburi | 11000 | Thailand |
| Chelsea & Westminster Hospital | London | SW10 9TH | United Kingdom |
| Result |
| Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350. |
| 28076335 | Result | Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11. |
| 26892863 | Result | Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731. |
| 27742226 | Result | Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11. |
| 26829661 | Result | Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940. |
| Result | Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015. |
| FG001 | E/C/F/TDF | Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for at least 144 weeks. Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences terminated the study in that country. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Extension Phase |
|
|
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E/C/F/TAF | E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks |
| BG001 | E/C/F/TDF | E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| HIV-1 RNA (log10 copies/mL) | Mean | Standard Deviation | log10 copies/mL |
| |||||||||||||||
| HIV-1 RNA Category | Count of Participants | Participants |
| ||||||||||||||||
| CD4 Cell Count | Mean | Standard Deviation | cells/µL |
| |||||||||||||||
| CD4 Cell Count Category | Count of Participants | Participants |
| ||||||||||||||||
| HIV Disease Status | 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: participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 48 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were 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 | Posted | Number | percentage of participants | Weeks 96 and 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were 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 | Posted | Number | percentage of participants | Weeks 48, 96. and 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Participants in the Full Analysis Set with on-treatment 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 on-treatment 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 on-treatment data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Hip DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Hip BMD at Week 96 | Hip BMD was assessed by DXA scan. | Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Hip BMD at Week 144 | Hip BMD was assessed by DXA scan. | Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Spine BMD at Week 48 | Spine BMD was assessed by DXA scan. | Spine DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Spine BMD at Week 96 | Spine BMD was assessed by DXA scan. | Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Spine BMD at Week 144 | Spine BMD was assessed by DXA scan. | Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine at Week 48 | Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline; Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine at Week 96 | Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline; Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine at Week 144 | Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline; Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. | Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed. | Posted | Number | percentage of participants | Up to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. | Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed. | Posted | Number | percentage of participants | Up to 96 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. | Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed. | Posted | Number | percentage of participants | Up to 144 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 144 |
|
|
Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
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 | Double-Blind: E/C/F/TAF | Adverse events reported in this group occurred during the Double-Blind Phase in participants who received E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks. | 73 | 435 | 380 | 435 | ||
| EG001 | Double-Blind: E/C/F/TDF | Adverse events reported in this group occurred during the Double-Blind Phase in participants who received E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks. | 65 | 432 | 375 | 432 | ||
| EG002 | Open-Label: E/C/F/TAF to E/C/F/TAF | Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country. | 0 | 90 | 16 | 90 | ||
| EG003 | Open-Label: E/C/F/TDF to E/C/F/TAF | Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country. | 1 | 94 | 14 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Atypical mycobacterial lower respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis of male external genital organ | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Eye infection syphilitic | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatitis syphilitic | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Neurosyphilis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Penile abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Secondary syphilis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Shigella infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Kidney contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Liver contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Scrotal haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Traumatic arthritis | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Uterine perforation | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Prognathism | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Retrognathia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Pleomorphic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vascular headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Drug use disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Substance use disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Substance-induced mood disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Post infection glomerulonephritis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alcohol detoxification | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
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 | 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 |
| ID | Term |
|---|---|
| D000069547 | Cobicistat |
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Other |
|
| Japan |
|
| United Kingdom |
|
| Thailand |
|
| Switzerland |
|
| Spain |
|
| Canada |
|
| Austria |
|
| Belgium |
|
| Italy |
|
| Australia |
|
| > 100,000 to ≤ 400,000 copies/mL |
|
| > 400,000 copies/mL |
|
| ≥ 50 to < 200 cells/µL |
|
| ≥ 200 to < 350 cells/µL |
|
| ≥ 350 to < 500 cells/µL |
|
| ≥ 500 cells/µL |
|
| Symptomatic HIV Infection |
|
| AIDS |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|