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
  Purpose

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
Acute Hepatitis C
HIV
HIV Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HIV positive men with acute HCV infection
2
HIV positive men who do not have acute HCV
3
Healthy controls

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV positive men with acute HCV infection

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959166

Locations
United Kingdom
St Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact: Lucy J Garvey       l.garvey@imperial.ac.uk   
Principal Investigator: Alan Winston         
Sub-Investigator: Lucy J Garvey         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Alan Winston Imperial College London
  More Information

No publications provided

Responsible Party: Dr Alan Winston, Imperial College, London
ClinicalTrials.gov Identifier: NCT00959166     History of Changes
Other Study ID Numbers: 09/H0712/17
Study First Received: August 13, 2009
Last Updated: May 25, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 15, 2014