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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004545-27 | EudraCT Number |
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This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E/C/F/TAF + LDV/SOF | Experimental | Part 1: Participants will switch from 2 nucleoside reverse transcriptase inhibitors (NRTI) plus a third agent to E/C/F/TAF. Part 2: After 8 weeks of E/C/F/TAF treatment, the participants maintaining HIV-1 RNA < 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study. |
|
| F/R/TAF + LDV/SOF | Experimental | Part 1: Participants will switch from 2 NRTI plus a third agent to F/R/TAF. Part 2: After 8 weeks of F/R/TAF treatment, the participants maintaining HIV-1 RNA < 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E/C/F/TAF | Drug | 150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) | Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment. | HCV Posttreatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment. | HCV Posttreatment Week 4 |
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm |
Not provided
Key Inclusion Criteria:
Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female individuals, without cirrhosis, treatment-naive or treatment-experienced with interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI).
Compensated cirrhotic individuals must be HCV treatment-naive.
No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except boceprevir, telaprevir and simeprevir, in combination with IFN and RBV
Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior to screening.
Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values ("blips") of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is allowed.
For individuals with 3 or more prior ARV regimens, a regimen history should be provided for approval by the Sponsor.
Plasma HIV-1 RNA level < 50 copies/mL at the screening visit
Have no documented resistance to any of the HIV study agents at time in the past, including but not limited to the reverse transcriptase resistance mutations K65R, K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L, the combination of K103N+L100I, or 3 or more thymidine analog associated mutations (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). If a historical genotype prior to first ARV is not available or individual had 3 or more prior ARV regimens, individual will have proviral genotype analysis for archived resistance prior to Day 1.
No history of HIV virologic failure
No evidence of Hepatitis B infection
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by Cockcroft-Gault formula
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Spectrum Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Ramgopal M, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster LB-12]. AASLD: The Liver Meeting 2017 20-24 October; Washington DC. | ||
| Result | Huhn G, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster PE16/52]. European AIDS Conference 2017 25-27 October; Milan Italy. | ||
| 31995556 | Derived | Huhn GD, Ramgopal M, Jain MK, Hinestrosa F, Asmuth DM, Slim J, Goldstein D, Applin S, Ryu JH, Jiang S, Cox S, Das M, Nguyen-Cleary T, Piontkowsky D, Guyer B, Rossaro L, Haubrich RH. HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens. PLoS One. 2020 Jan 29;15(1):e0224875. doi: 10.1371/journal.pone.0224875. eCollection 2020. |
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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.
259 participants were screened.
Participants were enrolled at study sites in the United States. The first participant was screened on 01 April 2016. The last study visit occurred on 29 September 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | E/C/F/TAF + LDV/SOF | Part 1: Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Dec 18, 2015 | Aug 10, 2018 |
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| F/R/TAF | Drug | 200/25/25 mg FDC tablet administered orally once daily |
|
|
| LDV/SOF | Drug | 90/400 mg FDC tablet administered orally once daily |
|
|
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were 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. |
| 24 weeks after start of HIV treatment |
| Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | Up to 32 weeks plus 30 days |
| Phoenix |
| Arizona |
| United States |
| Mills Clinical Research | Los Angeles | California | United States |
| Peter J Ruane MD Inc | Los Angeles | California | United States |
| University of California Davis | Sacramento | California | United States |
| University of California San Diego | San Diego | California | United States |
| Kaiser Permanente | San Francisco | California | United States |
| The George Washington University Medical Center | Washington D.C. | District of Columbia | United States |
| Whitman-Walker Health | Washington D.C. | District of Columbia | United States |
| Community AIDS Network | Clearwater | Florida | United States |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | United States |
| Therafirst Medical Center | Fort Lauderdale | Florida | United States |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| AIDS Healthcare Foundation | Miami | Florida | United States |
| AIDS Healthcare Foundation | Miami Beach | Florida | United States |
| Orlando Immunology Center | Orlando | Florida | United States |
| St. Josephs Comprehensive Research Institute | Tampa | Florida | United States |
| Triple O Research Institute PA | West Palm Beach | Florida | United States |
| Rowan Tree Medical PA | Wilton Manors | Florida | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | United States |
| Emory University | Atlanta | Georgia | United States |
| Chatham County Health Department | Savannah | Georgia | United States |
| The CORE Foundation | Chicago | Illinois | United States |
| Be Well Medical Center | Berkley | Michigan | United States |
| Kansas City Free Health Clinic | Kansas City | Missouri | United States |
| Saint Michael's Medical Center | Newark | New Jersey | United States |
| Weill Cornell Medical College | New York | New York | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States |
| Duke University | Durham | North Carolina | United States |
| East Carolina University | Greenville | North Carolina | United States |
| Lehigh Valley Health Network, Network Office of Research and Innovation | Allentown | Pennsylvania | United States |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | United States |
| Central Texas Clinical Research | Austin | Texas | United States |
| UT Southwestern Medical Center | Dallas | Texas | United States |
| Gordon E. Crofoot MD PA | Houston | Texas | United States |
| Therapeutics Concepts, PA | Houston | Texas | United States |
| Clinical Alliance for Research & Education | Annandale | Virginia | United States |
| Peter Shalit MD | Seattle | Washington | United States |
| Southern Cal | Spokane | Washington | United States |
| Community Health Care | Tacoma | Washington | United States |
| Clinical Research Puerto Rico Inc | San Juan | Puerto Rico |
| FG001 | F/R/TAF + LDV/SOF | Part 1: Participants received emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E/C/F/TAF + LDV/SOF | Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
| BG001 | F/R/TAF + LDV/SOF | Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
| 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 |
| ||||||||||||||||
| HCV RNA Category | Count of Participants | Participants |
| ||||||||||||||||
| HIV-1 RNA Category | Count of Participants | Participants |
| ||||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
|
| 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 HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) | Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment. | HCV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HCV study drug, LDV/SOF. | Posted | Number | 95% Confidence Interval | percentage of participants | HCV Posttreatment Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment. | HCV Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | HCV Posttreatment Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were 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. | HIV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HIV study drug, E/C/F/TAF or F/R/TAF. | Posted | Number | percentage of participants | 24 weeks after start of HIV treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | Safety Analysis Set (Whole Study): participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF). Safety Analysis Set (Part 2): participants who entered Part 2 of the study and received at least one dose of study drug LDV/SOF. | Posted | Number | percentage of participants | Up to 32 weeks plus 30 days |
|
Up to 32 weeks plus 30 days
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).
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 + LDV/SOF | Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). | 0 | 74 | 7 | 74 | 46 | 74 |
| EG001 | F/R/TAF + LDV/SOF | Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). | 1 | 74 | 12 | 74 | 36 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Testicular abscess | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
| |
| Blood pressure orthostatic abnormal | Investigations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Malignant neoplasm of unknown primary site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 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 | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | May 27, 2016 | Aug 10, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Nov 29, 2016 | Aug 10, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2017 | Aug 31, 2018 | SAP_003.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C000595958 | ledipasvir, sofosbuvir 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 |
|
| Black |
|
| White |
|
| Native Hawaiian or Pacific Islander |
|
| Other |
|
| American Indian or Alaska Native |
|
| ≥ 800,000 IU/mL |
|
| ≥ 50 copies/mL |
|
| 0.042 |
The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%. |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
Part 1: Participants received E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food for 8 weeks.
Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
| OG003 | F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12) | Part 1: Participants received F/R/TAF 200/25/25 mg tablet orally once daily with food for 8 weeks. Part 2: Participants continued receiving (F/R/TAF) 200/25/25 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
|
|