Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection - A Positron Emission Tomography (PET) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00959166
First received: August 13, 2009
Last updated: May 25, 2010
Last verified: May 2010

August 13, 2009
May 25, 2010
June 2009
June 2011   (final data collection date for primary outcome measure)
Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959166 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection - A Positron Emission Tomography (PET) Study
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

HIV positive men with acute HCV infection

  • Acute Hepatitis C
  • HIV
  • HIV Infections
Not Provided
  • 1
    HIV positive men with acute HCV infection
  • 2
    HIV positive men who do not have acute HCV
  • 3
    Healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2011
June 2011   (final data collection date for primary outcome measure)

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
Male
25 Years and older
Yes
Not Provided
United Kingdom
 
NCT00959166
09/H0712/17
No
Dr Alan Winston, Imperial College, London
Imperial College London
Not Provided
Principal Investigator: Alan Winston Imperial College London
Imperial College London
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP