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: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-003067-30-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-28
• Last Update Posted: 27 October 2014

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 within the last 3 months prior to Day 1 (other than prohibited HAART regimens (see section 3.4.1), which may be substituted at least one month 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;
?Laboratory values:
neutrophil count < 1500 cells/?L (<1200 cells/ ?L for blacks), platelet count < 90,000 cells/?L, hemoglobin < 11 g/dL for females, hemoglobin < 12 g/dL for males;
?Total bilirubin ? 34 ?mol/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