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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003067-30 | EudraCT Number |
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The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatsvir + Ribavirin + PEG-Interferon alfa-2a | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. | Follow-up Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND) | Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria:
Key Exclusion Criteria:
Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1. However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/ mL
Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
Laboratory values:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Scripps Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28210927 | Derived | Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Cote P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16. |
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Of 549 participants enrolled, 301 were randomized to receive treatment. Of the 248 participants who were not randomized, 204 no longer met study criteria, and 44 discontinued due to other reasons.
The study was conducted at 84 sites in 13 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Ribavirin | Drug | Tablets; oral; for patients weighing <75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing >75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response |
|
|
| PEG-Interferon alfa 2a | Drug | Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response |
|
|
| Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24 |
| Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. | Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24 |
| Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL | Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined. | End of treatment (up to Week 48) |
| Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | Percentages calculated as number of responders/number who received treatment. | Follow-up Week 12 |
| Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation | Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy. | From Day 1 to 7 days post last dose of study treatment (up to Week 48) |
| La Jolla |
| California |
| 92037 |
| United States |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | United States |
| Desert Medical Group Inc. | Palm Springs | California | 92262 | United States |
| Ucsd Antiviral Research Center | San Diego | California | 92103 | United States |
| San Francisco Gen Hosp | San Francisco | California | 94110 | United States |
| Kaiser Permanente Medical Center | San Francisco | California | 94118 | United States |
| Va Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| University Of Miami School Of Medicine | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Saint Michael'S Medical Center | Newark | New Jersey | 07102 | United States |
| Upper Delaware Valley Infectious Diseases, Pc | Monticello | New York | 12701 | United States |
| Icahn School Of Medicine At Mount Sinai | New York | New York | 10029 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| James J Peters Vamc | The Bronx | New York | 10468 | United States |
| University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Morehead Medical Plaza | Charlotte | North Carolina | 28204 | United States |
| Amelia Court Hiv Research Clinic | Dallas | Texas | 75235 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1181 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | C1181 | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Darlinghurst Nsw | New South Wales | 2010 | Australia |
| Local Institution | Clayton | Victoria | 3168 | Australia |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | Antwerp | 2000 | Belgium |
| Local Institution | Brussels | 1070 | Belgium |
| Local Institution | Brussels | B-1000 | Belgium |
| Local Institution | Rio de Janeiro | Rio de Janeiro | 20270 | Brazil |
| Local Institution | Rio de Janeiro | Rio de Janeiro | 21040 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035 | Brazil |
| Local Institution | São Paulo | São Paulo | 04035 | Brazil |
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local Institution | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution | Torono | Ontario | M5G 2N2 | Canada |
| Local Institution | Montreal | Quebec | H2L 4P9 | Canada |
| Local Institution | Montreal | Quebec | H2L 5B1 | Canada |
| Local Institution | Montreal | Quebec | H3A 1T1 | Canada |
| Local Institution | Marseille | 13274 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Paris | 75014 | France |
| Local Institution | Paris | 75018 | France |
| Local Institution | Paris | 75475 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Bonn | 53105 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Frankfurt am Main | 60311 | Germany |
| Local Institution | Hamburg | 20146 | Germany |
| Local Institution | Brescia | 25123 | Italy |
| Local Institution | Milan | 20127 | Italy |
| Local Institution | Milan | 20162 | Italy |
| Local Institution | Modena | 41100 | Italy |
| Local Institution | Torino | 10149 | Italy |
| Fundacion De Investigacion De Diego | San Juan | 00927 | Puerto Rico |
| University Of Puerto Rico School Of Medicine | San Juan | 00935 | Puerto Rico |
| Local Institution | Kaluga | 248023 | Russia |
| Local Institution | Lipetsk | 398043 | Russia |
| Local Institution | Moscow | 111123 | Russia |
| Local Institution | Nizhny Novgorod | 603005 | Russia |
| Local Institution | Saint Petersburg | 190103 | Russia |
| Local Institution | Saint Petersburg | 191167 | Russia |
| Local Institution | Saint Petersburg | 196645 | Russia |
| Local Institution | Saratov | 410009 | Russia |
| Local Institution | Volgograd | 400040 | Russia |
| Local Institution | Badalona | Barcelona | 08916 | Spain |
| Local Institution | Barcelona | 08003 | Spain |
| Local Institution | Córdoba | 14004 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28040 | Spain |
| Local Institution | Madrid | 28041 | Spain |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | Seville | 41014 | Spain |
| Local Institution | London | Greater London | SW10 9NH | United Kingdom |
| FG001 | HAART: Daclatasvir, 60 mg | Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| FG002 | HAART: Daclatasvir, 30 mg + 60 mg | Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| FG003 | Non--HAART Therapy | Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
All participants who received at least 1 dose of study therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| BG001 | HAART Therapy: Daclatasvir, 60 mg | Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| BG002 | HAART: Daclatasvir, 30 mg + 60 mg | Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| BG003 | Non-HAART Therapy: Daclatasvir, 60 mg | Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| BG004 | 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 at Follow-up Week 12 (SVR12) | SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. | The analysis was performed in all participants who received at least 1 dose of study therapy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Follow-up Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND) | Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. | The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan. | Posted | Number | Percentage of participants | Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. | The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan. | Posted | Number | Percentage of participants | Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL | Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined. | The analysis was performed in all participants who received at least 1 dose of study therapy | Posted | Number | 95% Confidence Interval | Percentage of participants | End of treatment (up to Week 48) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | Percentages calculated as number of responders/number who received treatment. | The analysis was performed in all participants who received at least 1 dose of study therapy. Here 'n' signifies number of participants evaluable at the specified time-point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Follow-up Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation | Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy. | The analysis was performed in all participants who received at least 1 dose of study drug. | Posted | Number | Participants | From Day 1 to 7 days post last dose of study treatment (up to Week 48) |
|
From Day 1 to 7 days post last dose of study treatment (up to Week 48)
On-treatment period
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 | Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. | 12 | 132 | 122 | 132 | ||
| EG001 | HAART Therapy: Daclatasvir, 60 mg | Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. | 6 | 39 | 38 | 39 | ||
| EG002 | HAART: Daclatasvir, 30 mg + 60 mg | Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. | 6 | 106 | 100 | 106 | ||
| EG003 | Non-HAART Therapy: Daclatasvir, 60 mg | Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. | 0 | 24 | 23 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Laryngeal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombophlebitis septic | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal dreams | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| 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 |
|---|---|
| C549273 | daclatasvir |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Lost to Follow-up |
|
| Death |
|
| Follow-up no longer required |
|
| 65 years and older |
|
| Male |
|
Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
|
|
|
|
| OG002 | HAART Therapy: Daclatasvir, 30mg + 60 mg | Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg),, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| OG003 | HAART Therapy: Daclatasvir 30 or 60 or 90 mg | Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
|
|
| OG002 | HAART Therapy: Daclatasvir, 30 mg + 60 mg | Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| OG003 | HAART Therapy: Daclatasvir 30, 60 or 90 mg | Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| OG004 | Non-HAART Therapy: Daclatasvir, 60 mg | Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
|
|
Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
| OG002 | HAART Therapy: Daclatasvir, 30 mg + 60 mg | Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| OG003 | HAART Therapy: Daclatasvir 30 or 60 or 90 mg | Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
| OG004 | Non-HAART Therapy: Daclatasvir, 60 mg | Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. |
|
|