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Health Condition(s) or Problem
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Acute Hepatitis C; HIV; HIV Infections
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Lay Summary
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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.
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
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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Sorry, not currently available
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Primary aim
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Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection
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Secondary Aim
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Association of CNS metabolite ratios and neurocognitive performance with acute HCV and HIV infection. Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios and neurocognitive performance.; 2 years; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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