To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Hepatitis C, HIV, HIV Infections

Intervention / Treatment
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* Other: PET scan


Participation Criteria
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Eligibility Criteria
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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 Male 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) Pregnancy Unable to give informed consent Any contraindication to MR scanning

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIV/acute HCV coinfection<br>Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test. | Other: PET scan<br>* PET brain scan<br>|
| Other: HIV mono<br>HIV-infected individuals without hepatitis C co-infection | Other: PET scan<br>* PET brain scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites | Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios. By quantifying the surrogate markers of N-acetylaspartate (NAA), creatine (Cr) offers insight into the neuronal integrity, cell membrane synthesis and turnover, macrophage infiltration, inflammation status, and levels of microglial activation and gliosis within the sampled CNS tissue. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute hepatitis C, HIV, Neurocognitive function, Neuroinflammation