An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Chronic (detectable HCV Ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL

• Confirmed diagnosis of HIV-1 infection greater than 6 months before the screening visit

• CD4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit

• HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit

• No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit

• Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks

Exclusion Criteria:

• Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period

• Infection or co-infection with HCV other than genotype 1

• Contraindication to the administration of Peg-IFN-alfa or RBV

• Hepatitis B virus (HBV) co-infection

• Acute or active condition of HIV-associated opportunistic infection within 6 months of screening