Efficacy and Safety Study of Pegylated Interferon Lambda-1a with Ribavirin and Daclatasvir, to treat na?ve subjects with chronic HCV Genotypes 1, 2, 3, and 4 who are co-infected with HIV.

Phase 1

• Conditions: Chronic Hepatitis C Virus (HCV) Infection (Genotypes 1, 2, 3, 4); MedDRA version: 16.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003280-22-BE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-20
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• HCV Genotype-1, -2, -3 or -4 treatment naïve;

• Male and females, 18 years of age and above

• HCV RNA = 10,000 IU/mL at screening;

• HIV-1 infection (approximately 200 subjects receiving HAART, approximately 100 subjects not receiving 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 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 6-40% OR
- Moderate defined as factor level activity of 1-5%

For additional inclusion criteria, please refer to Protocol section 3.3.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Any evidence of liver disease other than chronic HCV;

• Subjects infected with HIV-2;

• Diagnosed or suspected hepatocellular carcinoma;

• Decompensated liver disease;

• Presence of AIDS-defining opportunistic infections within 12 weeks prior to study entry;

• Laboratory values: ANC < 1.5 x 109 cells/L (< 1.2 x 109 cells/L for Black subjects), 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)

For additional exclusion criteria, please refer to Protocol section 3.3.2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified