Clinical Trials


Effects of HIV and Hepatitis C Virus on the Brain

This study has been completed
Icahn School of Medicine at Mount Sinai

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
Icahn School of Medicine at Mount Sinai Identifier

First received: June 28, 2007
Last updated: May 21, 2015
Last Verified: May 2015
History of Changes


This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.

HIV Infections
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV/HCV: Neuropsychiatric and Neurophysiological Features

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Enrollment: 78
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

HIV and HCV coinfected
HIV infected
HIV monoinfected
HIV/HCV nonviremnic
HIV and HCV coinfected with HCV RNA less than 600 copies
HCV infected
HCV monoinfected with HCV viremia

Detailed Description:

Hepatitis C is a liver disease that is caused by the hepatitis C virus (HCV). It can be successfully treated with 6 to 12 months of medication in both HIV infected and HIV uninfected people. Among HIV infected people, HCV infection is a common co-morbidity, and is more serious when it occurs in this population than others because it leads to liver damage more quickly. HIV is known to cause neurological deficits, and studies suggest that HCV may do so, as well. Knowledge about how to treat these deficits, however, is limited. More information about the nature of the neurological problems and their causes is needed to develop effective treatments. This study will determine the effects that HIV and HCV have on thinking abilities, such as memory, attention, and problem-solving, and whether the viruses affect brain chemistry.
Participants in this 4-year, observational study will undergo a series of tests and interviews. Participants may choose to complete all procedures over 2 days or three appointments. Procedures will include a 20-minute medical interview, a 4-hour neuropsychological evaluation, a 5-minute functional ability questionnaire, blood and urine collection (approximately 15 minutes), and a 1-hour magnetic resonance imaging (MRI) test of the head. The neuropsychological evaluation will test participants' memory, concentration, reasoning, and speed of thinking. All procedures will be completed over approximately 6 hours.



Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Probability Sample  

Study Population

HIV / HCV Coinfected, HIV moninfected, & HCV monoinfected


Inclusion Criteria:

  • CD4 count is greater than 200
  • Hepatitis C infected or uninfected
  • Speaks English

Exclusion Criteria:
  • Currently receiving interferon treatment for hepatitis C
  • History of neurological illness
  • Any psychotic spectrum disorder (e.g., schizophrenia or manic depression/bipolar disorder)
  • History of learning disability
  • History of head injury that entailed a loss of consciousness for more than 30 minutes
  • Any metal in body

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00494936


United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)


Principal Investigator: Elizabeth Ryan, PhD Icahn School of Medicine at Mount Sinai
More Information

More Information

Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00494936   History of Changes  
Other Study ID Numbers: GCO 03-0908  
Study First Received: June 28, 2007  
Last Updated: May 21, 2015  

Keywords provided by Icahn School of Medicine at Mount Sinai:

Treatment Naive
Treatment Experienced
HIV and HCV Coinfection

Additional relevant MeSH terms:
Hepatitis C
HIV Infections processed this data on July 20, 2018
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