Brain Deficits in HIV/HCV Coinfected People Before and After Anti-HCV Therapy
Brain Deficits in HIV/HCV Coinfected People Before and After Anti-HCV Therapy
This study will evaluate the impact of standard hepatitis C virus treatment on brain deficits
 in people who are infected with both HIV and the hepatitis C virus.
The World Health Organization estimates at least 3% of the world's population is infected
 with chronic hepatitis C virus (HCV), and up to one third of all HIV infected people are
 coinfected with HCV. HCV can damage the liver cells and cause liver diseases such as
 cirrhosis and hepatocellular carcinoma. People infected with HCV can also suffer from
 neurocognitive deficits, including problems with information processing, slowing of muscular
 processes related to thinking, and difficulty focusing on complex things. These
 neurocognitive deficits are similar to those found in HIV infected individuals, and previous
 research indicates that people infected with both HIV and HCV have greater overall cognitive
 impairments. This study aims to determine the impact of anti-HCV treatment on neurocognitive,
 neuropsychiatric, and neuroimaging factors in people infected with HCV and people coinfected
 with both HCV and HIV. The study also aims to measure whether possible neurocognitive
 improvements from anti-HCV treatment are related to a physical health outcome, measured as a
 sustained virologic response, and whether adherence to the medication schedule laid out for
 the participants influences possible positive effects on either neurocognitive or physical
 health.

 Two kinds of participants will be recruited for this study: those infected with HCV and those
 infected with both HCV and HIV. These two groups will be compared to determine how comorbid
 HCV and HIV infection affects treatment outcomes. The treatment specified for HCV is
 pegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients
 with chronic HCV. Participants will continue to see their doctors as regularly scheduled, and
 any other prescribed medications or advice concerning HCV treatment will be noted by
 researchers. All participants will be tested at baseline, after 12 weeks of treatment, and 12
 weeks after the completion of treatment. A subset from each group of participants will
 undergo additional neuroimaging tests. Participation in this study will last for varied
 amounts of time depending on the recommended treatments for HCV. Based on each virus'
 genotype and rapid virologic response, the treatment period for HCV may last 24 or 48 weeks,
 with further extensions of 12 to 24 weeks in some cases.

 During the three testing sessions, each lasting 5 hours, participants' health, cognitive
 functioning, and medication adherence will be measured. Testing will include self-report
 measures, intelligence tests, tasks designed to assess cognitive functioning, and motor
 functioning tasks. Urine tests screening for narcotics will also be collected. In addition to
 self-report measures, caps to pill bottles storing HCV medication will automatically record
 every time the cap is removed to measure adherence to the medication schedule.
Inclusion Criteria:

 -  Diagnosis of HCV with detectable HCV RNA in serum

 -  Meets clinical criteria for initiating HCV therapy

 -  Lives in the community and not in a board and care, nursing home, hospice, or other
 residential setting in which a professional caregiver would dispense necessary
 medication. Living with a partner, roommate, or other family members who may assist
 with caregiving, including reminding participants to take medication, is acceptable.

 -  Responsible for administering own medications

 -  Diagnosis of HIV-associated neurocognitive disorder (HAND) will not be cause for
 exclusion, so long as participant is able to demonstrate the ability to grant full
 informed consent

 -  HIV or HCV disease severity will not be cause for exclusion (e.g., CDC Groups A, B,
 and C are all eligible); although, if severely ill because of either HIV (e.g.,
 uncontrolled viremia, severely immunosuppressed) or HCV (e.g., cryoglobulinemia,
 hepatic encephalopathy) will not be eligible for PEG-IFN/RBV therapy

 -  Able to read English at the 6th grade level

 Exclusion Criteria:

 -  Current or past psychotic spectrum disorder, including schizophrenia, schizophreniform
 disorder, or bipolar disorder

 -  History of learning disability, seizure disorder, closed-head injury with loss of
 consciousness in excess of 30 minutes, or any other neurological disease

 -  Evidence of any central nervous system opportunistic infection or neoplasm

 -  Diagnosed with Hepatitis B

 -  Previous failed course of HCV therapy

 -  Those judged to be significantly depressed by the study psychiatrists/psychologists
 (defined as current major depressive disorder of moderate or severe severity) or with
 evidence of suicidal ideation will not be enrolled until clinical condition is
 stabilized.