HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
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Purpose
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.
| Condition |
|---|
|
HIV Infection Hepatitis C |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 1250 |
| 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) |
| Groups/Cohorts |
|---|
|
Main cohort
Adults infected with both HIV and Hepatitis C
|
|
Control Group
Adults at risk for liver disease, but not infected with both HIV and Hepatitis C
|
Detailed Description:
Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adults with HIV and Hepatitis C in the metropolitan Baltimore area. Preference given to those enrolled in the Johns Hopkins Infectious Diseases Outpatient Clinic.
Inclusion Criteria:
Co-Infected Arm
- Subject must be an HIV/HCV co-infected adult with HIV infection diagnosed by antibody testing and chronic HCV infection diagnosed by reactive HCV antibody and detectable plasma HCV RNA.
- Subject must receive medical care at the JHU HIV clinic or through the Viral Hepatitis Center.
- Subjects previously enrolled in the study cohort, but not currently receiving care in the Moore Clinic, may continue in the study.
- Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- Subject must be able to provide informed written consent.
Control Arm
- Subject must have or be at risk of having medical conditions that increase the risk of liver disease. These include, but are not limited to, HIV mono-infection, HCV mono-infection, Hepatitis B infection, alcohol addiction, and/or non-alcoholic steatohepatitis.
- Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- Subject must be able to provide informed written consent.
Exclusion Criteria:
- To avoid risks associated with ionizing radiation, female subjects may not be pregnant or breast feeding at the time of DEXA scanning. To avoid unknown risks to the fetus, female subjects may not be pregnant at the time of liver biopsy or FibroScan.
- To avoid interference with the DEXA scan, the subject may not have undergone a nuclear medicine exam with the past week and/or may not have undergone an x-ray procedure with contrast solution within the past 72 hours.
- To avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo FibroScan.
Contacts and Locations| Contact: Rosie Silva | 410-502-7134 | rsilva6@jhmi.edu |
| 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 |
More Information
Publications:
| Responsible Party: | David Thomas, Chief, Infectious Diseases, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01423643 History of Changes |
| Other Study ID Numbers: | NA00033421, R01DA013806 |
| Study First Received: | August 23, 2011 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
HIV Human immunodeficiency virus Acquired Immune Deficiency Syndrome Virus AIDS Virus Immunodeficiency Virus, Human Virus, Human Immunodeficiency |
Hepatitis C Hepatitis C, chronic Hepatitis C virus Hepatitis C antibodies Hepatitis C antigens |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Hepatitis, Viral, Human Fibrosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pathologic Processes Liver Diseases Digestive System Diseases Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013