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

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ClinicalTrials.gov Identifier: NCT00959166
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : February 22, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Acute Hepatitis C HIV HIV Infections

Study Design

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case Control
Time Perspective: Prospective
Official 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
Study Start Date : June 2009
Primary Completion Date : June 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

HIV positive men with acute HCV infection
HIV positive men who do not have acute HCV
Healthy controls

Outcome Measures

Primary Outcome Measures :
  1. Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV positive men with acute HCV infection

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959166

United Kingdom
St Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Principal Investigator: Alan Winston Imperial College London
More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00959166     History of Changes
Other Study ID Numbers: 09/H0712/17
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: May 2010

Keywords provided by Imperial College London:
Acute hepatitis C
Neurocognitive function

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis A
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Parasitic Diseases