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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00494936 |
This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.
Condition |
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HIV Infections Hepatitis C |
Study Type: | Observational |
Study Design: | Cohort, 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 |
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HIV/HCV
HIV and HCV coninfected
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HIV
HIV monoinfected
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HIV/HCV nonviremnic
HIV and HCV coinfected with HCV RNA less than 600 copies
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HCV
HCV monoinfected with HCV viremia
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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 |
HIV / HCV Coinfected, HIV moninfected, & HCV monoinfected
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Mount Sinai School of Medicine ( Elizabeth Ryan ) |
Study ID Numbers: | K23 MH71181, DAHBR 9A-ASNM |
Study First Received: | June 28, 2007 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00494936 |
Health Authority: | United States: Federal Government |
HIV HCV Treatment Naive Treatment Experienced HIV and HCV Coinfection |
Virus Diseases Hepatitis Liver Diseases Sexually Transmitted Diseases, Viral Digestive System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Hepatitis C Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Flaviviridae Infections |
Immune System Diseases Lentivirus Infections Infection |