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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002713-30 | EudraCT Number |
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The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E/C/F/TAF | Experimental | Participants will switch their current antiretroviral regimen to E/C/F/TAF and receive treatment for 96 weeks. After Week 96, participants in the United States (US) who wish to participate in the open-label (OL) rollover extension will continue to take E/C/F/TAF FDC until the End of E/C/F/TAF Visit. |
|
| Open-Label Rollover Extension B/F/TAF | Experimental | At Week 96 or the End of E/C/F/TAF Visit (whichever occurs last), participants will be given the option to receive open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E/C/F/TAF | Drug | 150/150/200/10 mg FDC tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48 | Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug or all AEs for participants still on E/C/F/TAF. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). | First Dose Date Up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96 | Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug for participants who did not participate in the BVY OL extension phase or the day prior to the date of the first B/F/TAF study drug dose for participants who participated in the BVY OL extension phase. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter J Ruane MD Inc | Los Angeles | California | United States | |||
| University of California Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30555051 | Background | Eron JJ Jr, Lelievre JD, Kalayjian R, Slim J, Wurapa AK, Stephens JL, McDonald C, Cua E, Wilkin A, Schmied B, McKellar M, Cox S, Majeed SR, Jiang S, Cheng A, Das M, SenGupta D. Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. Lancet HIV. 2018 Dec 13:S2352-3018(18)30296-0. doi: 10.1016/S2352-3018(18)30296-0. Online ahead of print. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.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.
75 participants were screened.
Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 14 December 2015. The last study visit occurred on 15 October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | E/C/F/TAF (GEN Phase) | Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| GEN Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2019 | Sep 10, 2020 |
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| B/F/TAF | Drug | 50/200/25 mg FDC tablets administered orally once daily |
|
|
| First Dose Date Up to Week 96 |
| GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 24 |
| GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 |
| GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 96 |
| Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV) | AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time). | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
| PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV | AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration. | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
| PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV | Cmax is defined as the maximum concentration of drug. | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
| PK Parameter: Ctau of EVG, COBI, FTC, and TFV | Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau has been presented in lieu of Cmin (specified in the protocol) to align with other Gilead studies. This change has no impact on the PK analysis as Ctau and Cmin are equivalent for all analytes. | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
| GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. | Week 96 |
| GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. | Week 96 |
| BVY OL Extension Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. | Week 48 of the BVY OL Extension Phase |
| GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96 | Baseline; Week 96 |
| BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48 | Baseline; Week 48 of the BVY OL Extension Phase |
| GEN Phase: Change From Baseline in CD4 Percentage at Week 96 | Baseline; Week 96 |
| BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48 | Baseline; Week 48 of the BVY OL Extension Phase |
| Sacramento |
| California |
| United States |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | United States |
| Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center | Orlando | Florida | United States |
| Triple O Research Institute PA | West Palm Beach | Florida | United States |
| Medical College of Georgia | Augusta | Georgia | United States |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | United States |
| Mercer University School of Medicine | Macon | Georgia | United States |
| The Research Institute | Springfield | Massachusetts | United States |
| Henry Ford Health System | Detroit | Michigan | United States |
| Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center | Newark | New Jersey | United States |
| University of North Carolina at Chapel Hill / UNC School of Medicine | Chapel Hill | North Carolina | United States |
| Duke University | Durham | North Carolina | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States |
| University of Cincinnati Med Center | Cincinnati | Ohio | United States |
| MetroHealth Medical Center IRB | Cleveland | Ohio | United States |
| North Texas Infectious Diseases Consultants | Dallas | Texas | United States |
| Trinity Health and Wellness Center | Fort Worth | Texas | United States |
| Gordon E. Crofoot MD PA | Houston | Texas | United States |
| Otto Wagner Spital | Vienna | Austria |
| Hopital Henri Mondor | Créteil | France |
| CHU de Nice-l Archet | Nice | France |
| Hopital Bichat-Claude Bernard | Paris | France |
| Hopital Saint Louis | Paris | France |
| Centre Hospitalier de Tourcoing | Tourcoing | France |
| Klinikum rechts der Isar, TUM | München | Germany |
| FG001 | E/C/F/TAF to B/F/TAF (BVY OL Extension Phase) | At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| BVY OL Extension Phase |
|
The GEN Safety Analysis Set included all participants who received at least 1 dose of GEN.
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| ID | Title | Description |
|---|---|---|
| BG000 | E/C/F/TAF (GEN Phase) | Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks. |
| 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 (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| HIV-1 RNA Category | Count of Participants | Participants |
| |||||||||||||||||||||||
| Cluster Determinant 4+ (CD4+) Cell Count | Mean | Standard Deviation | cells/µL |
| ||||||||||||||||||||||
| CD4+ Cell Count Categories | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| CD4 Percentage | Mean | Standard Deviation | percentage of CD4 cells |
|
| 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 | GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48 | Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug or all AEs for participants still on E/C/F/TAF. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). | The GEN Safety Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC). | Posted | Number | percentage of participants | First Dose Date Up to Week 48 |
|
|
| ||||||||||||||||||||||||||
| Secondary | GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96 | Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug for participants who did not participate in the BVY OL extension phase or the day prior to the date of the first B/F/TAF study drug dose for participants who participated in the BVY OL extension phase. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). | Participants in the GEN Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First Dose Date Up to Week 96 |
| ||||||||||||||||||||||||||||
| Secondary | GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | The GEN Full Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the GEN Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the GEN Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV) | AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time). | Participants in the PK Substudy Analysis Set (participants who were enrolled into the study, participated in the intensive PK substudy, received at least 1 dose of E/C/F/TAF FDC, and had at least 1 nonmissing plasma PK concentration value for any analyte of interest) with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV | AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV | Cmax is defined as the maximum concentration of drug. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | PK Parameter: Ctau of EVG, COBI, FTC, and TFV | Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau has been presented in lieu of Cmin (specified in the protocol) to align with other Gilead studies. This change has no impact on the PK analysis as Ctau and Cmin are equivalent for all analytes. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. | Participants in the GEN Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||
| Secondary | GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. | Participants in the GEN Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||
| Secondary | BVY OL Extension Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. | The BVY Full Analysis Set included all participants who were enrolled in the study and received at least 1 dose of BVY (B/F/TAF FDC). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 of the BVY OL Extension Phase |
|
| ||||||||||||||||||||||||||
| Secondary | GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96 | Participants in the GEN Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48 | Participants in the BVY Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 48 of the BVY OL Extension Phase |
|
| |||||||||||||||||||||||||||
| Secondary | GEN Phase: Change From Baseline in CD4 Percentage at Week 96 | Participants in the GEN Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of CD4 cells | Baseline; Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48 | Participants in the BVY Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of CD4 cells | Baseline; Week 48 of the BVY OL Extension Phase |
|
|
First dose date up to the last dose date [maximum: 114 Weeks (GEN Phase), 52 Weeks (BVY OL Extension Phase)] plus 30 days
The GEN Safety Analysis Set included all participants who received at least 1 dose of GEN.
The BVY Safety Analysis Set included all participants who received at least 1 dose of BVY.
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 | E/C/F/TAF (GEN Phase) | Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks. | 3 | 55 | 36 | 55 | 41 | 55 |
| EG001 | E/C/F/TAF to B/F/TAF (BVY OL Extension Phase) | At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks. | 0 | 10 | 3 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Large intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal transplant | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diabetic microangiopathy | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Subclavian vein stenosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Scleral hyperaemia | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acquired phimosis | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Superior vena cava stenosis | Vascular disorders | MedDRA 22.0 | 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 | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| SAP_005.pdf |
| Prot | Yes | No | No | Study Protocol: Original | Jul 8, 2015 | Sep 16, 2020 | Prot_006.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Oct 13, 2015 | Sep 16, 2020 | Prot_007.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Nov 28, 2016 | Sep 16, 2020 | Prot_008.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2.1 | May 1, 2018 | Sep 16, 2020 | Prot_009.pdf |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| Germany |
|
| >= 200 to < 350 cells/µL |
|
| >= 350 to < 500 cells/µL |
|
| >= 500 cells/µL |
|
| Units | Counts |
|---|---|
| Participants |
|
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