Overview

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