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
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Lead
Bristol-Myers Squibb
Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics
GT=genotype
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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%
You may not be if
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)
Clareo Health | 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
