Status:
COMPLETED
Brain Deficits in HIV/HCV Coinfected People Before and After Anti-HCV Therapy
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
HIV
Hepatitis C
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00747539
Start Date
July 1 2008
End Date
June 1 2015
Last Update
May 13 2016
Active Locations (4)
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1
Kaiser Permanente Infectious Diseases, Antelope Valley
Lancaster, California, United States, 93534
2
University of California, Los Angeles, School of Medicine
Los Angeles, California, United States, 90024
3
AIDS Healthcare Foundation
Los Angeles, California, United States, 90028
4
Veterans Administration Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073