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| Tracking Information | |||||||||
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| First Received Date † | June 28, 2007 | ||||||||
| Last Updated Date | March 23, 2009 | ||||||||
| Start Date † | May 2006 | ||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | Complete list of historical versions of study NCT00494936 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Effects of HIV and Hepatitis C Virus on the Brain | ||||||||
| Official Title † | HIV/HCV: Neuropsychiatric and Neurophysiological Features | ||||||||
| Brief Summary | 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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| 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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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Condition † |
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| Intervention † | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | Ryan EL, Morgello S, Isaacs K, Naseer M, Gerits P; The Manhattan HIV Brain Bank. Neuropsychiatric impact of hepatitis C on advanced HIV. Neurology. 2004 Mar 23;62(6):957-62. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 200 | ||||||||
| Estimated Completion Date | July 2009 | ||||||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00494936 | ||||||||
| Responsible Party | Elizabeth Ryan, Mount Sinai School of Medicine | ||||||||
| Secondary IDs †† | DAHBR 9A-ASNM | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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