HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
The chief purpose of this research is to understand how antiretroviral therapy (ART) affects progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The investigators study liver disease progression in a cohort of dually infected persons according to the success of ART.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||HCV/HIV Coinfection: Antiviral Therapy and Fibrosis|
- Fibrosis stage [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]Liver histologic fibrosis stage (Ishak 0 - 6)
- Body composition [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]Body composition measurements, derived from DEXA
- Liver stiffness [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]Liver stiffness, derived from liver elastography
- Serum markers [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]Serum levels of various chemical markers
- Liver histology [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]Liver histology as described by a pathologist
Biospecimen Retention: Samples Without DNA
Frozen serum and plasma samples. Liver biopsy fixed slides.
|Study Start Date:||March 2001|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Adults infected with both HIV and Hepatitis C
Adults at risk for liver disease, but not infected with both HIV and Hepatitis C
Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.
|Contact: Rosie Silvafirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator: David L. Thomas, MD|
|Principal Investigator:||David L. Thomas, MD||Johns Hopkins University|