Status:
TERMINATED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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:
- Mild-factor level activity of 6-4% OR
- Moderate defined as factor level activity of 1-5%
Exclusion
- 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)
Key Trial Info
Start Date :
July 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2015
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT01866930
Start Date
July 11 2013
End Date
August 27 2015
Last Update
June 13 2023
Active Locations (63)
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1
Inland Empire Liver Foundation
Rialto, California, United States, 92377
2
University Of California San Francisco
San Francisco, California, United States, 94110
3
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
4
University Of Colorado Denver & Hospital
Aurora, Colorado, United States, 80045