HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

NCT01423643 | Completed

• 2 other identifiers: NA00033421R01DA013806
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection; Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fibrosis stage

  Liver histologic fibrosis stage (Ishak 0 - 6)

  up to 15 years

Secondary Outcomes (4)

• Body composition

  up to 15 years

• Liver stiffness

  up to 15 years

• Serum markers

  up to 15 years

• Liver histology

  up to 15 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with HIV and Hepatitis C in the metropolitan Baltimore area. Preference given to those enrolled in the Johns Hopkins Infectious Diseases Outpatient Clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (8)

• 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.

  PMID: 21099664 BACKGROUND

• 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.

  PMID: 20186036 BACKGROUND

• 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.

  PMID: 19773633 BACKGROUND

• 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.

  PMID: 19236273 BACKGROUND

• 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;55(4):770-6. doi: 10.1016/j.jhep.2011.01.035. Epub 2011 Feb 19.

  PMID: 21338640 RESULT

• 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. doi: 10.1053/j.gastro.2010.11.052. Epub 2010 Dec 4.

  PMID: 21134375 RESULT

• 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. doi: 10.1097/QAD.0b013e3282f10de9.

  PMID: 18090048 RESULT

• 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. doi: 10.1097/QAD.0b013e32801086da.

  PMID: 17117023 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen serum and plasma samples. Liver biopsy fixed slides.

MeSH Terms

Conditions

HIV Infections; Hepatitis C; Acquired Immunodeficiency Syndrome; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Slow Virus Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David L. Thomas, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Infectious Diseases

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 26, 2011
• Study Start: March 1, 2001
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

US (1)