Brain Deficits in HIV/HCV Coinfected People Before and After Anti-HCV Therapy

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Interferon-alpha; Interferons; Ribavirin

Criteria

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.