Clinical trial NCT00494936: Effects of HIV and Hepatitis C Virus on the Brain
Official title: HIV/HCV: Neuropsychiatric and Neurophysiological Features
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Hepatitis C
Keywords: HIV
HCV
Treatment Naive
Treatment Experienced
HIV and HCV Coinfection
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-07-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV / HCV Coinfected, HIV moninfected, \& HCV monoinfected

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Elizabeth Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.