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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 28, 2007
July 2, 2007
May 25, 2015
May 2006
July 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00494936 on ClinicalTrials.gov Archive Site
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Effects of HIV and Hepatitis C Virus on the Brain
HIV/HCV: Neuropsychiatric and Neurophysiological Features
This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample
HIV / HCV Coinfected, HIV moninfected, & HCV monoinfected
  • HIV Infections
  • Hepatitis C
Not Provided
  • HIV/HCV
    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
Ryan EL, Morgello S, Isaacs K, Naseer M, Gerits P; Manhattan HIV Brain Bank. Neuropsychiatric impact of hepatitis C on advanced HIV. Neurology. 2004 Mar 23;62(6):957-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00494936
GCO 03-0908
K23MH071181 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASNM
No
Not Provided
Not Provided
Icahn School of Medicine at Mount Sinai
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
Icahn School of Medicine at Mount Sinai
May 2015