Effects of HIV and Hepatitis C Virus on the Brain

NCT ID: NCT00494936

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-07-31

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.

Conditions

HIV Infections; Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV/HCV

HIV and HCV coinfected

No interventions assigned to this group

HIV infected

HIV monoinfected

No interventions assigned to this group

HIV/HCV nonviremnic

HIV and HCV coinfected with HCV RNA less than 600 copies

No interventions assigned to this group

HCV infected

HCV monoinfected with HCV viremia

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

References

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. doi: 10.1212/01.wnl.0000115177.74976.6c.

Reference Type: BACKGROUND

PMID: 15037699 (View on PubMed)

Other Identifiers

K23MH071181

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 9A-ASNM

Identifier Type: -

Identifier Source: secondary_id

GCO 03-0908

Identifier Type: -

Identifier Source: org_study_id