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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002711-15 | EudraCT Number |
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The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen consisting of abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E/C/F/TAF | Experimental | Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks. |
|
| ABC/3TC+3rd Agent | Active Comparator | Participants will maintain prior regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to E/C/F/TAF FDC. Note: the prior regimen is determined by the participant's clinician (prior to entry into the study) and will consist of one of the third antiretroviral agents listed. |
|
| 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 |
|---|---|---|
| Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24 | The percentage of participants achieving 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
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Key Inclusion Criteria:
HIV-infected adult participants who meet the following criteria will be given the option to participate in the study:
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 |
|---|---|---|---|---|---|---|
| Spectrum Medical Group | Phoenix | Arizona | United States | |||
| Ruane Clinical Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | A Gori, G Rizzardini, C Miralles, J Olalla, JM Molina, F Raffi, P Kumar, A Antinori, M Ramgopal, HJ Stellbrink, M Das, H Chu, R Ram, W Garner, SK Chuck, D Piontkowsky, R Haubrich. Switching from An Abacavir (ABC)/Lamivudine (3TC)-Based Regimen to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) is Efficacious and Safe: Week 24 Primary Analysis of a Randomized Controlled Study in Virologically-Suppressed Adults [Presentation]. XVIII Congrès National de la SFLS, 19-20 October 2017, Nice Acropolis, France |
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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.
346 participants were screened.
Participants were enrolled at study sites in Europe and North America. The first participant was screened on 18 November 2015. The last study visit occurred on 24 Jan 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | E/C/F/TAF | Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg fixed dose combination (FDC) tablets administered orally once daily with food for 48 weeks |
| FG001 | ABC/3TC+3rd Agent |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Jul 31, 2015 | Jun 8, 2018 |
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| ABC/3TC | Drug | 600/300 mg tablets administered orally once daily |
|
|
| Third Antiretroviral Agent | Drug | Third antiretroviral agents could include one of the following:
Drug classes:
|
|
| Week 12 |
| Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm 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 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 |
| Change From Baseline in CD4+ Cell Count at Week 24 | Baseline; Week 24 |
| Change From Baseline in CD4+ Cell Count at Week 48 | Baseline; Week 48 |
| Los Angeles |
| California |
| 90036 |
| United States |
| Capital Medical Associates, P.C. | Washington D.C. | District of Columbia | United States |
| Georgetown University | Washington D.C. | District of Columbia | United States |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | United States |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | United States |
| Steinhart Medical Associates dba The Kinder Medical Group | Miami | Florida | United States |
| Triple O Research Institute PA | West Palm Beach | Florida | United States |
| The Positive Health Clinic, Allegheny Health Network | Pittsburgh | Pennsylvania | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| AIDS Arms, Inc./Trinity Health & Wellness Center | Dallas | Texas | 75208 | United States |
| Tarrant County ID Associates | Fort Worth | Texas | 76104 | United States |
| CHU - Groupe Saint-Andre | Bordeaux | France |
| Hopital Henri Mondor | Créteil | France |
| Hopital Europeen Marseille | Marseille | France |
| C.H.U. de Nantes | Nantes | France |
| C.H.U. de NICE | Nice | France |
| CHU Hotel Dieu | Paris | France |
| Hopital Lariboisiere | Paris | France |
| Hopital Necker les Enfants Malades | Paris | France |
| Hopital Saint Antoine | Paris | France |
| Hopital Saint Louis | Paris | France |
| Centre Hospitalier Gustave Dron | Tourcoing | France |
| Epimed GmbH | Berlin | Germany |
| Universitatsklinikum Essen | Essen | Germany |
| ICH Study Center Hamburg | Hamburg | Germany |
| Universitatsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| ARNAS Garibaldi - Nesima | Catania | Italy |
| Unit Infectious Diseases - University of Catania - ARNAS Garibaldi | Catania | Italy |
| Azienda Ospedaliera Luigi Sacco | Milan | Italy |
| Azienda Ospedaliero Universitaria Policlinico di Modena | Modena | Italy |
| Azienda Ospedale San Paolo | Monza | Italy |
| Azienda Ospedaliera San Gerardo | Monza | Italy |
| Ospedale Civile S. Spirito AUSL | Pescara | Italy |
| Unità Operativa Complessa di Malattie Infettive | Pescara | Italy |
| Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S. | Roma | Italy |
| Comprensorio Ospedaliero Amedeo di Savoia | Torino | Italy |
| Dipartimento di Malattie Infettive e Tropicali | Torino | Italy |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Costa Del Sol | Marbella | Spain |
| Hospital Reg. Univ. Carlos Haya | Málaga | Spain |
| Hospital Clínico Universitario de Valencia (Galindo) | Valencia | Spain |
| Hospital General Universitario de Valencia (Abril) | Valencia | Spain |
| Hospital Alvaro Cunqueiro | Vigo | Spain |
| Mortimer Market Centre | London | United Kingdom |
Abacavir/lamivudine (ABC/3TC) 600/300 mg tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who took at least 1 dose of E/C/F/TAF or ABC/3TC+3rd Agent (on or after Day 1).
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| ID | Title | Description |
|---|---|---|
| BG000 | E/C/F/TAF | E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks |
| BG001 | ABC/3TC+3rd Agent | ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC |
| 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 |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| HIV-1 RNA Categories | Count of Participants | Participants |
| ||||||||||||||||
| CD4 Cell Count | Mean | Standard Deviation | cells/µL |
| |||||||||||||||
| CD4 Cell Count Category | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24 | The percentage of participants achieving 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. | Full Analysis Set: participants who were randomized and received at least one dose of study drug (either E/C/F/TAF or ABC/3TC+3rd agent on or after Day 1). | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Full Analysis Set | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm 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 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. | Only the participants who were randomized to E/C/F/TAF group were analyzed. | Posted | Number | percentage of participants | Week 48 |
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| Secondary | Change From Baseline in CD4+ Cell Count at Week 24 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 24 |
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| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Participants in the E/C/F/TAF group with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 48 |
|
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Up to 48 weeks plus 30 days
The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows:
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| 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 | E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks | 0 | 183 | 12 | 183 | 71 | 183 |
| EG001 | ABC/3TC+3rd Agent | ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC | 0 | 91 | 1 | 91 | 21 | 91 |
| EG002 | Delayed E/C/F/TAF | Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food. | 0 | 89 | 4 | 89 | 17 | 89 |
| EG003 | All E/C/F/TAF | Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF. Participants received E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food. | 0 | 272 | 16 | 272 | 88 | 272 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 20.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | 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 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Jun 1, 2016 | Jun 8, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2018 | Jun 8, 2018 | SAP_002.pdf |
| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C492871 | abacavir, lamivudine 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 |
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| Male |
|
| Black |
|
| White |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Permitted |
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| Italy |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| Spain |
|
| 50 ≥ copies/mL |
|
| ≥ 200 to < 350 cells/µL |
|
| ≥ 350 to < 500 cells/µL |
|
| ≥ 500 cells/µL |
|
| Units | Counts |
|---|
| Participants |
|
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| Categories |
|---|
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