chronic hepatitis C virus infection MedDRA version: 15.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
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 during that time: efavirenz, ATV/r or raltegravir-based regimens that contain nucleos(t)ide backbones of tenofovir or abacavir plus lamivudine or emtricitabine - Male and female subjects 18 to 65 years of age, inclusive - Female subjects must not be pregnant (negative pregnancy test at Screening and Day 1) or planning to become pregnant within 6 months after the last dose of ribavirin, 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the hepatitis C antiviral efficacy of telaprevir, peginterferon alfa-2a, and ribavirin;Secondary Objective: - To assess safety and tolerability of telaprevir, peginterferon alfa-2a, and ribavirin - To evaluate the pharmacokinetics of telaprevir, peginterferon alfa-2a, and ribavirin, and select highly active antiretroviral therapies - To monitor amino acid sequence changes in the HCV NS3•4A protease region;Primary end point(s): Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug;Timepoint(s) of evaluation of this end point: Study Week 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) - Proportion of subjects who achieve undetectable HCV RNA at Week 4 (RVR), Week 4 and 12 (eRVR), and planned End of Treatment (EOT) - Safety as assessed by AEs, clinical laboratory results, HIV RNA assessments, CD4 counts, 12-lead electrocardiogram (ECGs), and vital signs - PK of telaprevir, Peg-IFN, RBV, and selected HAART medications - Amino acid sequence of the HCV NS3•4A protease region;Timepoint(s) of evaluation of this end point: Study Week 72 | — |
Countries
Canada, Germany, Mexico, Spain, United States
Contacts
Public ContactMedical Information Center
Vertex Pharmaceuticals Incorporated
Outcome results
None listed