Effects of HIV and Hepatitis C Virus on the Brain

Study Overview
=================
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.

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.

Official Title
-----------------
HIV/HCV: Neuropsychiatric and Neurophysiological Features

Conditions
-----------------
HIV Infections, Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV/HCV<br>HIV and HCV coinfected | |
| HIV infected<br>HIV monoinfected | |
| HIV/HCV nonviremnic<br>HIV and HCV coinfected with HCV RNA less than 600 copies | |
| HCV infected<br>HCV monoinfected with HCV viremia | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, HCV, Treatment Naive, Treatment Experienced, HIV and HCV Coinfection