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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003467-12 | EudraCT Number |
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The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir + Sofosbuvir | Experimental | Daclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
| ||
| Sofosbuvir |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with SVR12 | SVR12 rate defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4 | Post treatment follow-up week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR12) rate | SVR12 rate defined as HCV RNA < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection, by individual genotype (1-4) | Approximately 2 years |
| Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada | ||
| Local Institution |
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|
| Approximately 2 years |
| Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF | Approximately 2 years |
| Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF | Approximately 2 years |
| Proportion of subjects receiving cART who maintain HIV virologic suppression | Approximately 2 years |
| Proportion of subjects receiving cART who experience HIV virologic failure | Approximately 2 years |
| Vancouver |
| British Columbia |
| V6Z 2C7 |
| Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local Institution | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution | Toronto | Ontario | M5G 2N2 | Canada |
| Local Institution | Montreal | Quebec | H4A 3J1 | Canada |
| Local Institution | Québec | Quebec | G1V 4G2 | Canada |
| Local Institution | Regina | Saskatchewan | S4P 0W5 | Canada |
| Local Institution | Marseille | 13009 | France |
| Local Institution | Nantes | 44093 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Paris | 75010 | France |
| Local Institution | Paris | 75015 | France |
| Local Institution | Paris | 75020 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Paris | 75877 | France |
| Local Institution | Pessac | 33604 | France |
| 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 |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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