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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Acute Hepatitis C
  • HIV
  • HIV Infections
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Male
Age Range
25 Years - N/A
Who Can Participate
Sorry, this information is not available
Number of Participants
Sorry, this information is not available
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
This is in the inclusion criteria above
Trial Location(s)
GSK Investigational Site
London
W2 1NY
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
09/H0712/17
Sponsor(s)
Imperial College London
Key Dates

Recruitment Start Date

Jun 2009

Recruitment End Date

Jun 2011

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

13 Aug 2009

Last Updated

03 Jun 2015