MedPath

Safety and Efficacy study of BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in untreated Hepatitis C Patients Coinfected with HIV Virus

Conditions
Chronic Hepatitis C / HIV-1 co-infection
MedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2011-003067-30-BE
Lead Sponsor
Bristol-Myers Squibb International Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
500
Inclusion Criteria

•Males and females, 18 to 70 years of age;
•HCV Genotype 1a or 1b;
•HCV-Treatment naive;
•HCV RNA > 10,000 IU/mL at screening;
•HIV-1 infection;(approximately 250 subjects receiving HAART, up to 50 subjects not receiving HAART);
•For subjects receiving HAART, HIV RNA must be below < 40 copies/mL at screening and must be < 400 copies/ml for at least 6 months prior to screening;
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 475
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Subjects (receiving HAART) who had first initiated anti-retroviral therapy within the last 6 months of Day 1;
•Subjects (receiving HAART) who have changed their anti-retroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months 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. Subject 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 (receiving HAART) who have changed their anti-retroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1;
•Use of prohibited HAART regimens (see section 3.4.1) within one month of Day 1 and throughout the treatment period of the trial. For those subjects requiring HAART therapy modifications for study entry, a repeat HIV RNA level is required prior to Day 1 after the modification is
applied, to confirm study eligibility;
•Laboratory values: neutrophil count < 1500 cells/µL (<1200 cells/ µL for blacks), platelet count < 90,000 cells/µL, hemoglobin < 12 g/dL for females, hemoglobin < 13 g/dL for males;
•Total bilirubin = 34 µmol/L (or = 2 mg/dL) unless subject has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath