A study to investigate the safety and effectiveness of telaprevir in combination with peginterferon alfa-2a and ribavirin in treating chronic hepatitis C virus infection in subjects who are co-infected with hepatitis C virus and immunodeficiency virus (HIV).

Conditions: chronic hepatitis C virus 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: EUCTR2011-002668-25-ES

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

- Subjects must have chronic, genotype 1a or 1b, hepatitis C at Screening
- Subjects must have a diagnosis of HIV-1 infection >6 months before Screening
- Taking 1 of the following permissible HAART regimens for HIV continuously >/=12 weeks before Day 1 without switches
- Male and female subjects 18 to 65 years of age, inclusive
- Female subjects must not be pregnant or planning to become pregnant within 72 weeks after enrolling in the study, or they must be permanently sterile or otherwise of nonchildbearing potential. Female subjects must also not be breastfeeding.
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 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
- Evidence of hepatic decompensation
- Clinical suspicion of acute hepatitis
- Any other cause of liver disease in addition to hepatitis C
- Diagnosed or suspected hepatocellular carcinoma
- Pre-existing psychiatric condition
- Medical condition that requires frequent or prolonged use of systemic corticosteroids
- Previous treatment with an HCV protease inhibitor