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Clinical Trials

MainTitle

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV (DIMENSION)

This study has been completed
Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT01866930

First received: May 29, 2013
Last updated: March 22, 2017
Last Verified: March 2017
History of Changes
Purpose

Purpose

To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Condition Intervention Phase
Chronic Hepatitis C Infection

Biological : Pegylated Interferon Lambda-1a
Drug : Daclatasvir (DCV)
Drug : Ribasphere (RBV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures

  • Antiviral activity, as determined by the proportion of subjects with SVR12, defined as HCV RNA [ Time Frame: Post treatment Week 12 ]
    SVR=Sustained virologic response HCV=Hepatitis C virus RNA=Ribonucleic acid LLOQ=Lower Limit of Quantification
Secondary Outcome Measures:
  • Proportion of subjects with Rapid virologic response (RVR) and Extended Rapid Virologic Response (eRVR), where RVR is defined as [ Time Frame: RVR at Week 4 and eRVR at Weeks 4 and 12 ]
  • Proportion of subjects in each group/duration who achieve HCV RNA [ Time Frame: 24 weeks post treatment (SVR24) ]
  • Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb <10 g/dL, and/or neutropenia as defined by ANC <750 mm3 and/or thrombocytopenia as defined by platelets <50,000 mm3) during the treatment period [ Time Frame: Weeks 1, 2, 4, 6, 8, 12, 20, and 24 (and Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits) ]
    Hb=Hemoglobin ANC=Absolute Neutrophil Count
  • Proportion of subjects with the following on treatment IFN-associated symptoms: flu-like symptoms (as defined by pyrexia or chills or pain) and musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12, 20, and 24 (and Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits) ]
    IFN=Interferon
  • Frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), dose reductions, and severity Grade 3/4 laboratory abnormalities [ Time Frame: From Day 1 until the end of treatment 24 weeks or 48 weeks: Weeks 1, 2, 4, 6, 8, 12, 20, and 24 (and Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits) ]
  • Absolute and percent change from baseline in the CD4 cell count, lymphocyte cell count, and platelet count [ Time Frame: Weeks 4, 8, 12 and 24 (and Week 36 for subjects requiring visit) ]

Enrollment: 453
Study Start Date: July 11, 2013
Study Completion Date: August 27, 2015
Primary Completion Date: August 27, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Cohort A: GT-2 or -3 HCV Treatment Naïve Subjects
Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 weeks Ribasphere 200 mg tablets (800 mg per day: two 200 mg tablets in the morning and two 200 mg tablets in the evening) by mouth twice daily for 24 weeks Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks
Biological: Pegylated Interferon Lambda-1a
Other Name: BMS-914143
Drug: Daclatasvir (DCV)
Other Name: BMS-790052
Drug: Ribasphere (RBV)
Experimental: Cohort B: GT-1 or -4 HCV Treatment Naïve Subjects
Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 or 48 weeks Ribasphere 200 mg tablets, (1000 mg per day: two 200 mg tablets in the morning and three 200 mg tablets in the evening for subjects weighing <75 kg and 1200 mg per day: three 200 mg tablets in morning and three 200 mg tablets in evening for subjects weighing ≥75 kg) by mouth twice daily for 24 or 48 weeks Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks
Biological: Pegylated Interferon Lambda-1a
Other Name: BMS-914143
Drug: Daclatasvir (DCV)
Other Name: BMS-790052
Drug: Ribasphere (RBV)

Detailed Description:

Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics
GT=genotype

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • HCV Genotype-1, -2, -3 or -4 treatment naïve;
  • HCV RNA ≥10,000 IU/mL at screening;
  • HIV-1 infection [(approximately 200 subjects receiving HAART, approximately 100 subjects not receiving highly active antiretroviral therapy (HAART)];
  • For subjects receiving HAART, HIV RNA must be below <40 copies/mL at screening and <200 copies/mL for at least 8 weeks prior to screening;
  • CD4 cell count at screening must be ≥100 cells/μL if receiving HAART or ≥350 cells/μL if not receiving HAART)
  • Seronegative for Hepatitis B Surface Antigen (HBsAg)
  • Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI=weight (kg)/[height (m)]2 at screening;
  • Subjects with compensated cirrhosis are permitted, but the number of subjects will be capped at approximately 30%. If a subject does not have cirrhosis, a liver biopsy within 3 years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. Fibroscan® or FibroTest are acceptable if performed within 1 year prior to treatment in countries where liver biopsy is not required prior to treatment and where non-invasive imaging tests are approved for staging of liver disease
  • Subjects with mild to moderate hemophilia as defined as:
    1. Mild-factor level activity of 6-4% OR
    2. Moderate defined as factor level activity of 1-5%


Exclusion Criteria:
  • Any evidence of liver disease other than chronic HCV;
  • Subjects infected with human immunodeficiency virus (HIV-2);
  • Diagnosed or suspected hepatocellular carcinoma;
  • Decompensated liver disease;
  • Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC, (CDC, JAMA 1993 Feb 10;269(6):729-30)
  • Laboratory values: ANC <1.5 x 109 cells/L (<1.2 x 109 cells/L for Blacks), platelet count <90 x 109 cells/L, hemoglobin <11 g/dL for females, hemoglobin <12 g/dL for males;
  • Subjects (receiving HAART) who had first initiated anti-retroviral therapy within last 8 weeks prior to Day 1; however, if changes are required to a subject's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. Subjects should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/mL
  • Subjects on Zidovudine (AZT), Didanosine (ddI), or Stavudine (d4T);
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Subjects with severe hemophilia (defined as <1% factor activity level)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866930

Locations

United States, California
Inland Empire Liver Foundation
Rialto, California, United States, 92377
University Of California San Francisco
San Francisco, California, United States, 94110
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
United States, Colorado
University Of Colorado Denver
Aurora, Colorado, United States, 80045
University Of Colorado Denver
Denver, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Florida
Orlando Va Medical Center
Orlando, Florida, United States, 32803
United States, Georgia
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States, 30308
Emory University
Atlanta, Georgia, United States, 30308
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18102
United States, Texas
Ut Southwestern Medical Center
Dallas, Texas, United States, 75235
Argentina
Local Institution
Buenos Aires, Bs As, Buenos Aires, Argentina, 1141
Local Institution
Mar Del Plata, Buenos Aires, Argentina, 7600
Local Institution
Quilmes, Buenos Aires, Argentina, 1878
Local Institution
Buenos Aires, Argentina, 1119
Local Institution
Buenos Aires, Argentina, 1202
Belgium
Local Institution
Antwerpen, Belgium, 2000
Local Institution
Bruxelles, Belgium, 1000
Local Institution
Bruxelles, Belgium, 1200
Canada
University Of Alberta Hospitals
Edmonton, Alberta, Canada, T6G 2B7
St Pauls Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Vancouver Id Reserach & Care Centre Society
Vancouver, British Columbia, Canada, V6Z 2C7
Hamilton Health Sciences, Mcmaster Site
Hamilton, Ontario, Canada, L8V 1C3
Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6
Mcgill University Health Centre (Muhc) Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
France
Local Institution
Le Kremlin Bicetre, France, 94275
Local Institution
Lyon, France, 69317
Local Institution
Paris, France, 75010
Local Institution
Paris, France, 75020
Local Institution
Pessac Cedex, France, 33604
Germany
Local Institution
Berlin, Germany, 13353
Local Institution
Bonn, Germany, 53105
Local Institution
Hamburg, Germany, 20146
Italy
Local Institution
Antella (fi), Italy, 50011
Local Institution
Brescia, Italy, 25123
Local Institution
Milano, Italy, 20127
Local Institution
Monza, Italy, 20052
Local Institution
Roma, Italy, 00149
Mexico
Local Institution
Ciudad Juarez, Chihuahua, Mexico, 35350
Local Institution
Mexico, Distrito Federal, Mexico, 14080
Local Institution
Leon, Guanajuato, Mexico, 37320
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Poland
Local Institution
Lodz, Poland, 91-347
Local Institution
Wroclaw, Poland, 50-220
Russian Federation
Local Institution
Moscow, Russian Federation, 105275
Local Institution
Moscow, Russian Federation, 111123
Local Institution
Saint Petersburg, Russian Federation, 190103
Local Institution
St. Petersburg, Russian Federation, 196645
Local Institution
Volgograd, Russian Federation, 400040
Spain
Local Institution
Barcelona, Spain, 08029
Local Institution
Cartagena (Murcia), Spain, 30202
Local Institution
Donosti-San Sebastian, Spain, 20014
Local Institution
Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28041
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW10 9TH
Local Institution
Brighton, United Kingdom, BN2 5BE
Local Institution
London, United Kingdom, W2 1NY

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

More Information

Additional Information:

BMS Clinical Trial Information

Additional Information:

BMS clinical trial educational resource

Additional Information:

Investigator Inquiry form

Additional Information:

FDA Safety Alerts and Recalls

Additional Information:

BMS Clinical Trial Patient Recruiting

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT01866930   History of Changes  
Other Study ID Numbers: AI452-032  
  2012-003280-22  
Study First Received: May 29, 2013  
Last Updated: March 22, 2017  

Additional relevant MeSH terms:
Infection
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Interferons
Ribavirin

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.