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CompletedNCT00494936Updated May 25, 2015

Effects of HIV and Hepatitis C Virus on the Brain

An observational study in HIV Infections and Hepatitis C, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-05-25.

Sponsored by Icahn School of Medicine at Mount Sinai · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
78
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • HIV Infections
  • Hepatitis C

Keywords

  • HIV
  • HCV
  • Treatment Naive
  • Treatment Experienced
  • HIV and HCV Coinfection
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 78 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

HIV / HCV Coinfected, HIV moninfected, \& HCV monoinfected

Inclusion criteria

  • CD4 count is greater than 200
  • Hepatitis C infected or uninfected
  • Speaks English

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
78 participants (actual)

Groups and cohorts

  • 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

06

Study locations

1 site
  • Mount Sinai School of Medicine
    New York, New York 10029-6574, United States
07

References and documents

Publications

  • 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. PubMed 15037699 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00494936
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jul 2, 2007
Start date
May 2006
Primary completion
Jul 2009
Completion
Jul 2009
Last update
May 25, 2015

Study contacts

Elizabeth Ryan, PhD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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