Effects of HIV and Hepatitis C Virus on the Brain

HIV Infections Clinical Trial

Official title:

HIV/HCV: Neuropsychiatric and Neurophysiological Features

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494936
• Other study ID #: GCO 03-0908
• Secondary ID: K23MH071181DAHBR
• Status: Completed
• Phase: N/A
• First received: June 28, 2007
• Last updated: May 21, 2015
• Start date: May 2006
• Est. completion date: July 2009

Study information

• Verified date: May 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV Infections

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ryan EL, Morgello S, Isaacs K, Naseer M, Gerits P; Manhattan HIV Brain Bank. Neuropsychiatric impact of hepatitis C on advanced HIV. Neurology. 2004 Mar 23;62(6):957-62. — View Citation