Hepatitis C, Genotype 1 Clinical Trial
Official title:
A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)
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
| Status | Completed |
| Enrollment | 549 |
| Est. completion date | September 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com Key Inclusion Criteria: - Males and females, 18 to 70 years of age - Hepatitis C virus (HCV) genotype 1a or 1b - HCV-treatment naive - HCV RNA >10,000 IU/mL at screening - HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy [HAART], up to 50 patients not receiving HAART) - For patients receiving HAART, HIV RNA must be below <40 copies/mL at screening and must be <400 copies/ml for at least 6 months prior to screening 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: 1. Neutrophil count <1500 cells/µL (<1200 cells/ µL for Blacks) 2. Platelet count <90,000 cells/µL 3. Hemoglobin =12 g/dL for females, hemoglobin =13 g/dL for males 4. Total bilirubin =34 µmol/L (or =2 mg/dL) unless a patient has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir 5. Alanine aminotransferase =5*upper limit of normal |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Ciudad De Buenos Aires | Buenos Aires |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | Prov De Santa Fe | Santa Fe |
| Australia | Local Institution | Clayton | Victoria |
| Australia | Local Institution | Darlinghurst | New South Wales |
| Australia | Local Institution | Darlinghurst Nsw | New South Wales |
| Australia | Local Institution | Parkville | Victoria |
| Belgium | Local Institution | Antwerpen | |
| Belgium | Local Institution | Brussels | |
| Belgium | Local Institution | Brussels | |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution | Rio De Janeiro | |
| Brazil | Local Institution | Rio De Janeiro | |
| Brazil | Local Institution | Sao Paulo | |
| Canada | Local Institution | Edmonton | Alberta |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Ottawa | Ontario |
| Canada | Local Institution | Torono | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| Canada | Local Institution | Vancouver | British Columbia |
| Canada | Local Institution | Victoria | British Columbia |
| France | Local Institution | Marseille Cedex 09 | |
| France | Local Institution | Montpellier Cedex 5 | |
| France | Local Institution | Paris | |
| France | Local Institution | Paris | |
| France | Local Institution | Paris | |
| France | Local Institution | Paris | |
| France | Local Institution | Paris Cedex 10 | |
| France | Local Institution | Pessac Cedex | |
| Germany | Local Institution | Berlin | |
| Germany | Local Institution | Bonn | |
| Germany | Local Institution | Frankfurt | |
| Germany | Local Institution | Frankfurt Am Main | |
| Germany | Local Institution | Hamburg | |
| Italy | Local Institution | Brescia | |
| Italy | Local Institution | Milano | |
| Italy | Local Institution | Milano | |
| Italy | Local Institution | Modena | |
| Italy | Local Institution | Torino | |
| Puerto Rico | Fundacion De Investigacion De Diego | San Juan | |
| Puerto Rico | University Of Puerto Rico School Of Medicine | San Juan | |
| Russian Federation | Local Institution | Kaluga | |
| Russian Federation | Local Institution | Lipetsk | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | Nizhniy Novgorod | |
| Russian Federation | Local Institution | Saratov | |
| Russian Federation | Local Institution | St. Petersburg | |
| Russian Federation | Local Institution | St. Petersburg | |
| Russian Federation | Local Institution | St.petersburg | |
| Russian Federation | Local Institution | Volgograd | |
| Spain | Local Institution | Badalona | Barcelona |
| Spain | Local Institution | Barcelona | |
| Spain | Local Institution | Cordoba | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Sevilla | |
| United Kingdom | Local Institution | London | Greater London |
| United States | University Of Alabama At Birmingham | Birmingham | Alabama |
| United States | James J Peters Vamc | Bronx | New York |
| United States | University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina |
| United States | Morehead Medical Plaza | Charlotte | North Carolina |
| United States | Amelia Court Hiv Research Clinic | Dallas | Texas |
| United States | Baylor College Of Medicine | Houston | Texas |
| United States | Scripps Clinic | La Jolla | California |
| United States | Southern California Permanente Medical Group | Los Angeles | California |
| United States | Johns Hopkins University | Lutherville | Maryland |
| United States | University Of Miami School Of Medicine | Miami | Florida |
| United States | Upper Delaware Valley Infectious Diseases, Pc | Monticello | New York |
| United States | Icahn School Of Medicine At Mount Sinai | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Saint Michael'S Medical Center | Newark | New Jersey |
| United States | Orlando Immunology Center | Orlando | Florida |
| United States | Desert Medical Group Inc. | Palm Springs | California |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Texas Liver Institute | San Antonio | Texas |
| United States | Ucsd Antiviral Research Center | San Diego | California |
| United States | Kaiser Permanente Medical Center | San Francisco | California |
| United States | San Francisco Gen Hosp | San Francisco | California |
| United States | Georgetown University Hospital | Washington | District of Columbia |
| United States | Va Connecticut Healthcare System | West Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Puerto Rico, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Follow-up Week 12 | No |
| 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. | Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24 | No |
| 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. | 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 | No |
| 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. | End of treatment (up to Week 48) | No |
| 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. | Follow-up Week 12 | No |
| 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. | From Day 1 to 7 days post last dose of study treatment (up to Week 48) | Yes |