Effects of HIV and Hepatitis C Virus on the Brain

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00494936

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Hepatitis C

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 Design

Study Type:

Observational

Actual Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

HIV/HCV: Neuropsychiatric and Neurophysiological Features

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
HIV/HCV HIV and HCV coinfected
HIV infected HIV monoinfected
HIV/HCV nonviremnic HIV and HCV coinfected with HCV RNA less than 600 copies
HCV infected HCV monoinfected with HCV viremia

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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