CTN 222: HIV-HCV study
Brief Title: CTN 222: HIV-HCV study
Overall Lead: Dr. Marina Klein
Local Study Lead: Dr. Neora Pick, Medical Director, Oak Tree Clinic
Official Title: A Prospective Clinical Cohort of HIV and Hepatitis C Virus Co infected Patients – expansion to a cross-Canada study entitled: “If HCV is an OI Why Has HAART Not Improved Liver Disease?” (CTN 222); Prospective Investigation of the Relationship Between Food Insecurity and Health and Behavioural Outcomes in HIV-HCV Co-Infection: Clues for Prevention Interventions (CTN 264)
1. Food Security – CTN 264
Prospective Investigation of the Relationship Between Food Insecurity and Health and Behavioural Outcomes in HIV-HCV Co-Infection: Clues for Prevention Interventions
Novel Approaches to Studying Liver Fibrosis – Transient Elastography (FibroScan)
Summary: Many people who have HIV infection are also infected with hepatitis C virus (HCV). In these people liver disease is becoming an increasing cause of illness and death. Furthermore treatment of HIV is complicated by the presence of liver disease, and treatment of HCV is complicated by HIV. The purpose of this study is to examine a group of patients infected with both HIV and the Hepatitis C Virus, to understand how these two infections interact and to measure the impact of treatment on the course of their disease and on quality of life.
The Food Security sub-study looks at the relationship between 1) levels of food security, 2) behavioural and clinical factors related to HIV-HCV co-infection, and 3) health-related quality of life and health and treatment outcomes among co-infected patients participating in HIV care in Canada.
The purpose of the FibroScan sub-study is to see whether FibroScans, rapid and relatively painless procedure, can be used to help measure liver fibrosis resulting from HIV-HCV co-infection.
What does this study involve?
Participation in this study involves a structured questionnaire every six months over a period of five years. A sample of blood will be collected for study with each questionnaire. Participants enrolled in the Food Security sub-study will be asked to fill out a second questionnaire at the same time as their main study visit for a period of up to two years.
Participants in the FibroScan sub-study will be asked to undergo a FibroScan every six months for a period of up to five years. The FibroScan is a non-invasive procedure that uses sound waves to examine the liver, similar to an ultrasound.
Study dates: March 2008 – July 2014
Target enrolment number: 95 for the Oak Tree site, 1050 in total
Open or closed recruitment:
Recruitment in the main study is closed except for patients at Oak Tree Clinic who will be starting Hepatitis C therapy
Recruitment in the Food Security study is open to existing participants in the main study
Recruitment in the FibroScan study is only open to existing participants in the main study who are starting HIV treatment for the first time, are starting Hepatitis C treatment, or who have had a liver biopsy in the past year or are scheduled for a liver biopsy in the next year
Contact information: Sara O’Shaughnessy, Research Coordinator, 604-875-2000 ext. 6861, SOShaughnessy@cw.bc.ca