HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

Hepatitis C Clinical Trial

Official title:

HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423643
• Other study ID #: NA00033421
• Secondary ID: R01DA013806
• Status: Completed
• Phase: N/A
• First received: August 23, 2011
• Last updated: February 22, 2016
• Start date: March 2001
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Co-Infected Arm

1. 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.

2. Subject must receive medical care at the JHU HIV clinic or through the Viral Hepatitis Center.

3. Subjects previously enrolled in the study cohort, but not currently receiving care in the Moore Clinic, may continue in the study.

4. Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.

5. Subject must be able to provide informed written consent.

Control Arm

1. 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.

2. Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.

3. Subject must be able to provide informed written consent.

Exclusion Criteria:

1. 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.

2. 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.

3. To avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo FibroScan.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coinfection
• Hepatitis C
• HIV Infection

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Balagopal A, Ray SC, De Oca RM, Sutcliffe CG, Vivekanandan P, Higgins Y, Mehta SH, Moore RD, Sulkowski MS, Thomas DL, Torbenson MS. Kupffer cells are depleted with HIV immunodeficiency and partially recovered with antiretroviral immune reconstitution. AIDS. 2009 Nov 27;23(18):2397-404. doi: 10.1097/QAD.0b013e3283324344. — View Citation

Brown TT, Mehta SH, Sutcliffe C, Higgins Y, Torbenson MS, Moore RD, Thomas DL, Sulkowski MS. Hepatic steatosis associated with increased central body fat by dual-energy X-ray absorptiometry and uncontrolled HIV in HIV/hepatitis C co-infected persons. AIDS. 2010 Mar 27;24(6):811-7. doi: 10.1097/QAD.0b013e3283333651. — View Citation

El-Maouche D, Mehta SH, Sutcliffe C, Higgins Y, Torbenson MS, Moore RD, Thomas DL, Sulkowski MS, Brown TT. Controlled HIV viral replication, not liver disease severity associated with low bone mineral density in HIV/HCV co-infection. J Hepatol. 2011 Oct;5 — View Citation

Kirk GD, Astemborski J, Mehta SH, Spoler C, Fisher C, Allen D, Higgins Y, Moore RD, Afdhal N, Torbenson M, Sulkowski M, Thomas DL. Assessment of liver fibrosis by transient elastography in persons with hepatitis C virus infection or HIV-hepatitis C virus coinfection. Clin Infect Dis. 2009 Apr 1;48(7):963-72. doi: 10.1086/597350. — View Citation

Mehta SH, Lucas GM, Mirel LB, Torbenson M, Higgins Y, Moore RD, Thomas DL, Sulkowski MS. Limited effectiveness of antiviral treatment for hepatitis C in an urban HIV clinic. AIDS. 2006 Nov 28;20(18):2361-9. — View Citation

Salgado M, Kirk GD, Cox A, Rutebemberwa A, Higgins Y, Astemborski J, Thomas DL, Thio CL, Sulkowski MS, Blankson JN. Protective interleukin-28B genotype affects hepatitis C virus clearance, but does not contribute to HIV-1 control in a cohort of African-American elite controllers/suppressors. AIDS. 2011 Jan 28;25(3):385-7. doi: 10.1097/QAD.0b013e328341b86a. — View Citation

Sulkowski MS, Mehta SH, Torbenson MS, Higgins Y, Brinkley SC, de Oca RM, Moore RD, Afdhal NH, Thomas DL. Rapid fibrosis progression among HIV/hepatitis C virus-co-infected adults. AIDS. 2007 Oct 18;21(16):2209-16. — View Citation

Woreta TA, Sutcliffe CG, Mehta SH, Brown TT, Higgins Y, Thomas DL, Torbenson MS, Moore RD, Sulkowski MS. Incidence and risk factors for steatosis progression in adults coinfected with HIV and hepatitis C virus. Gastroenterology. 2011 Mar;140(3):809-17. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrosis stage	Liver histologic fibrosis stage (Ishak 0 - 6)	up to 15 years	No
Secondary	Body composition	Body composition measurements, derived from DEXA	up to 15 years	No
Secondary	Liver stiffness	Liver stiffness, derived from liver elastography	up to 15 years	No
Secondary	Serum markers	Serum levels of various chemical markers	up to 15 years	No
Secondary	Liver histology	Liver histology as described by a pathologist	up to 15 years	No