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

Completed

Conditions studied: HIV, Hepatitis C, Infections

In brief

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.

Key facts

Study ID

NCT00747539

Run by

University of California, Los Angeles

People needed

330

Starts

2008-07-01

Expected to finish

2015-06-01

Last updated by the study team

2016-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente Infectious Diseases, Antelope Valley — Lancaster, California, United States
• University of California, Los Angeles, School of Medicine — Los Angeles, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Veterans Administration Greater Los Angeles Healthcare System — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.