We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Effects of HIV and Hepatitis C Virus on the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00494936
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : May 25, 2015
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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

Condition or disease
HIV Infections Hepatitis C

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.

Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV/HCV: Neuropsychiatric and Neurophysiological Features
Study Start Date : May 2006
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00494936     History of Changes
Other Study ID Numbers: GCO 03-0908
K23MH071181 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2007    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases