A Prospective Case-control Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-infection - a PET Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Hepatitis C
- Sponsor
- Imperial College London
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study plans to evaluate what happens to the brain in patients with HIV and early hepatitis C. The investigators will be comparing 3 groups of individuals:
- Group 1: Individuals with HIV infection and acute (early) hepatitis C infection
- Group 2: Individuals with HIV infection
- Group 3: Healthy volunteers
Detailed Description
Subtle changes to the brain, which doctors find difficult to detect through conversation or examination, may occur in patients with HIV and/or hepatitis C infection. It is not currently known whether the brain is affected in early (or acute) hepatitis C. Individuals wishing to take part will complete a series of tests assessing different aspects of their brain including: * 2 brain scans using different technology: * Magnetic resonance imaging (MRI) brain scan with spectroscopy * CT PET brain scan * A computer game test which measures brain function * 2 short questionnaires Results of these tests will be analyzed and compared between 3 groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV-1 antibody positive for at least 12 months
- •Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months)
- •HCV genotype 1
- •Ability to give informed consent
- •Aged \> 25 years
- •Abbreviated Mental Test Score of at least 8/10
Exclusion Criteria
- •Evidence of established cirrhosis or encephalopathy
- •Commencing or any change to HIV medications within 12 weeks
- •Active opportunistic infection
- •Taking anti-depressants or any psychoactive medications within past 4 weeks
- •Use of benzodiazepines within past 4 weeks
- •Recent significant head injury
- •Established dementia
- •Alcohol dependence or recreational drug misuse
- •Untreated early syphilis
- •Hepatitis B infection (HBsAg positive)
Outcomes
Primary Outcomes
Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection
Time Frame: 30 days
Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.
Secondary Outcomes
- Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites(30 days)