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Completed

NCT Number: NCT00494936

Effects of HIV and Hepatitis C Virus on the Brain

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

HIV/HCV: Neuropsychiatric and Neurophysiological Features

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 2, 2007
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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