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

NCT ID: NCT01866930

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-11
• Study Completion Date: 2015-08-27

Brief Summary

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

Detailed Description

Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics

GT=genotype

Conditions

Chronic Hepatitis C Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pegylated Interferon Lambda-1a

Intervention Type: BIOLOGICAL

Daclatasvir (DCV)

Intervention Type: DRUG

Ribasphere (RBV)

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Pegylated Interferon Lambda-1a

Intervention Type: BIOLOGICAL

Daclatasvir (DCV)

Intervention Type: DRUG

Ribasphere (RBV)

Intervention Type: DRUG

Interventions

Pegylated Interferon Lambda-1a

Intervention Type: BIOLOGICAL

Daclatasvir (DCV)

Intervention Type: DRUG

Ribasphere (RBV)

Intervention Type: DRUG

Other Intervention Names

BMS-914143; BMS-790052

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Inland Empire Liver Foundation

Rialto, California, United States

University Of California San Francisco

San Francisco, California, United States

Kaiser Permanente Medical Center

San Francisco, California, United States

University Of Colorado Denver & Hospital

Aurora, Colorado, United States

University Of Colorado Denver

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Orlando Va Medical Center

Orlando, Florida, United States

Emory Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Mercy Medical Center

Baltimore, Maryland, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Ut Southwestern Medical Center

Dallas, Texas, United States

Local Institution

Buenos Aires, Bs As, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Quilmes, Buenos Aires, Argentina

Local Institution

Buenos Aires, , Argentina

Local Institution

Buenos Aires, , Argentina

Local Institution

Antwerp, , Belgium

Local Institution

Brussels, , Belgium

Local Institution

Brussels, , Belgium

University Of Alberta Hospitals

Edmonton, Alberta, Canada

St Pauls Hospital

Vancouver, British Columbia, Canada

Vancouver Id Reserach & Care Centre Society

Vancouver, British Columbia, Canada

Hamilton Health Sciences, Mcmaster Site

Hamilton, Ontario, Canada

Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Mcgill University Health Centre (Muhc) Montreal Chest Institute

Montreal, Quebec, Canada

Local Institution

Le Kremlin-Bicêtre, , France

Local Institution

Lyon, , France

Local Institution

Paris, , France

Local Institution

Paris, , France

Local Institution

Pessac, , France

Local Institution

Berlin, , Germany

Local Institution

Bonn, , Germany

Local Institution

Bonn, , Germany

Local Institution

Hamburg, , Germany

Local Institution

Antella (fi), , Italy

Local Institution

Brescia, , Italy

Local Institution

Milan, , Italy

Local Institution

Monza, , Italy

Local Institution

Roma, , Italy

Local Institution

Ciudad Juárez, Chihuahua, Mexico

Local Institution

León, Guanajuato, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Mexico City, Mexico City, Mexico

Local Institution

Lodz, , Poland

Local Institution

Wroclaw, , Poland

Local Institution

Moscow, , Russia

Local Institution

Moscow, , Russia

Local Institution

Saint Petersburg, , Russia

Local Institution

Saint Petersburg, , Russia

Local Institution

Volgograd, , Russia

Local Institution

Barcelona, , Spain

Local Institution

Cartagena (Murcia), , Spain

Local Institution

Donosti-San Sebastian, , Spain

Local Institution

Madrid, , Spain

Local Institution

Madrid, , Spain

Local Institution

London, Greater London, United Kingdom

Local Institution

Brighton, , United Kingdom

Local Institution

London, , United Kingdom

Local Institution

London, , United Kingdom

Local Institution

London, , United Kingdom

Countries

United States; Argentina; Belgium; Canada; France; Germany; Italy; Mexico; Poland; Russia; Spain; United Kingdom

References

Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S. Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.

Reference Type: DERIVED

PMID: 28282271 (View on PubMed)

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

Other Identifiers

2012-003280-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AI452-032

Identifier Type: -

Identifier Source: org_study_id