Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection - A Positron Emission Tomography (PET) Study | Completed
Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection - A Positron Emission Tomography (PET) Study
Health Conditions
  • Acute Hepatitis C
  • HIV
  • HIV Infections
Completed
Recruitment Status
NCT00959166
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection; 2 years
Secondary Outcome Measures
  • 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
Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Male
Participant Age Range
25 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
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Design Details
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Study Design
Observational Model: Case Control, Time Perspective: Prospective
Results Reporting
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Acronym
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Scientific Title
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
Secondary Trial Identifying Number
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Website
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Study Funded By
Imperial College London
Funder Type
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Study Sponsored By
Imperial College London
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

13 Aug 2009

Last Updated

03 Jun 2015

Date Record Refreshed on UKCTG

31 Jul 2015