Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of HIV and Hepatitis C Virus on the Brain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Information provided by:
National Institute of Mental Health (NIMH) Identifier:
First received: June 28, 2007
Last updated: March 23, 2009
Last verified: March 2009

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

Resource links provided by NLM:

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 200
Study Start Date: May 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
HIV and HCV coninfected
HIV monoinfected
HIV/HCV nonviremnic
HIV and HCV coinfected with HCV RNA less than 600 copies
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
Genders Eligible for Study:   Both
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
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

Contact: Elizabeth Ryan, PhD 212-659-8803
Contact: Will Rausch, BSc 212-659-9149

United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029-6574
Contact: Elizabeth Ryan, PhD    212-659-8803   
Contact: Will Rausch, BSc    212-659-9149   
Principal Investigator: Elizabeth Ryan, PhD         
Sponsors and Collaborators
Principal Investigator: Elizabeth Ryan, PhD Mount Sinai School of Medicine
  More Information

Additional Information:
Responsible Party: Elizabeth Ryan, Mount Sinai School of Medicine Identifier: NCT00494936     History of Changes
Other Study ID Numbers: K23 MH071181, DAHBR 9A-ASNM
Study First Received: June 28, 2007
Last Updated: March 23, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Treatment Naive
Treatment Experienced
HIV and HCV Coinfection processed this record on March 03, 2015