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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004812-12 | EudraCT Number |
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The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF | Experimental | LDV/SOF FDC for 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 90/400 mg FDC tablet administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug. | Posttreatment Week 4 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment |
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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 |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28397698 | Derived | Rockstroh JK, Bhagani S, Hyland RH, Yun C, Dvory-Sobol H, Zheng W, Brainard DM, Ingiliz P, Lutz T, Boesecke C, Nelson M. Ledipasvir-sofosbuvir for 6 weeks to treat acute hepatitis C virus genotype 1 or 4 infection in patients with HIV coinfection: an open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2017 May;2(5):347-353. doi: 10.1016/S2468-1253(17)30003-1. Epub 2017 Mar 1. |
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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.
34 participants were screened.
Participants were enrolled at study sites in Germany and the United Kingdom. The first participant was screened on 11 June 2015. The last study visit occurred on 8 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF | Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Weeks 2, 4, and 6 |
| Change From Baseline in HCV RNA at Weeks 2, 4, and 6 | Baseline; Weeks 2, 4, and 6 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 12 |
| Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study. | Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates. | Day 1; Week 6 |
| Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 | Weeks 2, 4, 6, and Posttreatment Week 4 |
| Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4 | Baseline; Week 6; Posttreatment Week 4 |
| Bonn |
| Germany |
| Frankfurt am Main | Germany |
| London | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF | LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| IL28b Status | Count of Participants | Participants |
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| HCV Genotype | Count of Participants | Participants |
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| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
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| HCV RNA Category | Count of Participants | Participants |
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| CD4 Counts | Mean | Standard Deviation | cells/uL |
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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 With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Full Analysis Set: participants with genotype 1 or 4 HCV infection who were enrolled into the study and received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Up to 6 weeks |
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| Secondary | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 4 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 2, 4, and 6 |
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| Secondary | Change From Baseline in HCV RNA at Weeks 2, 4, and 6 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 2, 4, and 6 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 12 |
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| Secondary | Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study. | Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates. | Safety Analysis Set | Posted | Count of Participants | Participants | Day 1; Week 6 |
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| Secondary | Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 | Participants in the Safety Analysis Set who had HIV-1 RNA < 50 copies/mL at Baseline were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 2, 4, 6, and Posttreatment Week 4 |
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| Secondary | Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 6; Posttreatment Week 4 |
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Up to 6 weeks plus 30 days
Safety Analysis Set
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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 | LDV/SOF | LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks | 1 | 26 | 20 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Syphilis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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There were no limitations affecting the analysis or results.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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| Asian |
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| Hispanic or Latino |
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| Not Hispanic or Latino |
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| Not Disclosed |
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| TT |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Week 2 |
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| Week 4 |
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| Week 6 |
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| Change at Week 2 |
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| Change at Week 4 |
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| Change at Week 6 |
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| Title | Denominators | Categories |
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| Week 2 |
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| Week 4 |
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| Week 6 |
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| Posttreatment Week 4 |
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| Denominators |
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| Change at Week 6 |
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| Change at Posttreatment Week 4 |
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