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

A Phase 3, Open Label Study of Safety and Efficacy with BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) + Pharmacogenetics Blood Sample Amendment 01, version 1.0 dated 06-Oct-11

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003067-30-GB

Enrollment

500

Registered

2011-12-12

Start date

2012-02-08

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C / HIV-1 co-infection MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: BMS-790052 Product Code: BMS-790052 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: daclatasvir Current Spons

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

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/µL (<1200 cells/ µL for blacks), platelet count < 90,000 cells/µL, hemoglobin < 11 g/dL for females, hemoglobin < 12 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess efficacy, as determined by the proportion of subjects with SVR12, defined as HCV RNA < Limit of quantification (LOQ) detectable or undetectable, at post-treatment Week 12.; Secondary Objective: • To assess the proportion of subjects with genotype 1 infection who achieve : -HCV RNA < LOQ (detectable or undetectable) -HCV RNA undetectable at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, post-treatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12) • To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs • To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA = 400 copies/mL at end of treatment for subjects who are receiving HAART • To assess the relationship between efficacy and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene ;Primary end point(s): Proportion of subjects with SVR12, defined as HCV RNA < LOQ (detectable or undetectable) at post-treatment Week 12;Timepoint(s) of evaluation of this end point: Follow-up Week 12	—

Measure

Time frame

Main Objective: To assess efficacy, as determined by the proportion of subjects with SVR12, defined as HCV RNA < Limit of quantification (LOQ) detectable or undetectable, at post-treatment Week 12.; Secondary Objective: • To assess the proportion of subjects with genotype 1 infection who achieve : -HCV RNA < LOQ (detectable or undetectable) -HCV RNA undetectable at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, post-treatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12) • To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs • To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA = 400 copies/mL at end of treatment for subjects who are receiving HAART • To assess the relationship between efficacy and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene ;Primary end point(s): Proportion of subjects with SVR12, defined as HCV RNA < LOQ (detectable or undetectable) at post-treatment Week 12;Timepoint(s) of evaluation of this end point: Follow-up Week 12

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Secondary

Measure	Time frame
Secondary end point(s): 1. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, post-treatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12). 2. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; both Weeks 4 and 12; EOT, post-treatment Week 12; post-treatment Week 24; and post-treatment Week 48 for subjects who achieve VR (4&12). 3. To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs; 4. To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA = 400 copies/mL at end of treatment for subjects who are receiving HAART; 5. Proportion of subjects with SVR12 at post treatment Week 12 by the rs12979860 in the IL28B gene. ; Timepoint(s) of evaluation of this end point: 1. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Week 24 and post-treatment Week 48 for subjects who achieve VR (4 & 12). 2. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Weeks 12, 24 and post-treatment Week 48 for subjects who achieve VR (4 &12). 3. Throughout treatment period 4. End of treatment 5. Post-treatment Week 12	—

Measure

Time frame

Secondary end point(s): 1. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, post-treatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12). 2. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; both Weeks 4 and 12; EOT, post-treatment Week 12; post-treatment Week 24; and post-treatment Week 48 for subjects who achieve VR (4&12). 3. To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs; 4. To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA = 400 copies/mL at end of treatment for subjects who are receiving HAART; 5. Proportion of subjects with SVR12 at post treatment Week 12 by the rs12979860 in the IL28B gene. ; Timepoint(s) of evaluation of this end point: 1. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Week 24 and post-treatment Week 48 for subjects who achieve VR (4 & 12). 2. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Weeks 12, 24 and post-treatment Week 48 for subjects who achieve VR (4 &12). 3. Throughout treatment period 4. End of treatment 5. Post-treatment Week 12

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Countries

Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Puerto Rico, Russian Federation, Spain, United Kingdom, United States

Contacts

Public ContactEU Study Start-Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026