- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00494936
Effects of HIV and Hepatitis C Virus on the Brain
HIV/HCV: Neuropsychiatric and Neurophysiological Features
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029-6574
- Mount Sinai School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HIV/HCV
HIV and HCV coinfected
|
HIV infected
HIV monoinfected
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HIV/HCV nonviremnic
HIV and HCV coinfected with HCV RNA less than 600 copies
|
HCV infected
HCV monoinfected with HCV viremia
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elizabeth Ryan, PhD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 03-0908
- DAHBR 9A-ASNM
- K23MH071181 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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