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

Imperial College London81 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Acute Hepatitis C HIV HIV Infections

Interventions

PET scanOTHER

PET brain scan

Eligibility

Sex: MALEMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. HIV-1 antibody positive for at least 12 months 2. Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months) 3. HCV genotype 1 4. Ability to give informed consent 5. Aged \> 25 years 6. Male 7. Abbreviated Mental Test Score of at least 8/10 Exclusion Criteria: 1. Evidence of established cirrhosis or encephalopathy 2. Commencing or any change to HIV medications within 12 weeks 3. Active opportunistic infection 4. Taking anti-depressants or any psychoactive medications within past 4 weeks 5. Use of benzodiazepines within past 4 weeks 6. Recent significant head injury 7. Established dementia 8. Alcohol dependence or recreational drug misuse 9. Untreated early syphilis 10. Hepatitis B infection (HBsAg positive) 11. Pregnancy 12. Unable to give informed consent 13. Any contraindication to MR scanning

Locations (1)

St Mary's Hospital

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 30 days

Data from ClinicalTrials.gov

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