Effects of HIV and Hepatitis C Virus on the Brain
Recruitment status was Recruiting
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This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.
Condition |
---|
HIV Infections Hepatitis C |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | HIV/HCV: Neuropsychiatric and Neurophysiological Features |
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) |
Groups/Cohorts |
---|
HIV/HCV
HIV and HCV coninfected
|
HIV
HIV monoinfected
|
HIV/HCV nonviremnic
HIV and HCV coinfected with HCV RNA less than 600 copies
|
HCV
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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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
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Contact: Elizabeth Ryan, PhD | 212-659-8803 | elizabeth.ryan@mssm.edu |
Contact: Will Rausch, BSc | 212-659-9149 | william.rausch@mssm.edu |
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 elizabeth.ryan@mssm.edu | |
Contact: Will Rausch, BSc 212-659-9149 william.rausch@mssm.edu | |
Principal Investigator: Elizabeth Ryan, PhD |
Principal Investigator: | Elizabeth Ryan, PhD | Mount Sinai School of Medicine |
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Additional Information:
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Publications:
Responsible Party: | Elizabeth Ryan, Mount Sinai School of Medicine |
ClinicalTrials.gov 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):
HIV HCV Treatment Naive Treatment Experienced HIV and HCV Coinfection |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on March 03, 2013