Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection - A Positron Emission Tomography (PET) Study
Recruitment status was Recruiting
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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 |
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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 |
- Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 |
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1
HIV positive men with acute HCV infection
|
2
HIV positive men who do not have acute HCV
|
3
Healthy controls
|
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HIV positive men with acute HCV infection
Inclusion Criteria:
- HIV-1 antibody positive for at least 12 months
- Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months)
- HCV genotype 1
- Ability to give informed consent
- Aged > 25 years
- Male
- Abbreviated Mental Test Score of at least 8/10
Exclusion Criteria:
- Evidence of established cirrhosis or encephalopathy
- Commencing or any change to HIV medications within 12 weeks
- Active opportunistic infection
- Taking anti-depressants or any psychoactive medications within past 4 weeks
- Use of benzodiazepines within past 4 weeks
- Recent significant head injury
- Established dementia
- Alcohol dependence or recreational drug misuse
- Untreated early syphilis
- Hepatitis B infection (HBsAg positive)
- Pregnancy
- Unable to give informed consent
- Any contraindication to MR scanning
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 |
Principal Investigator: | Alan Winston | Imperial College London |
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 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 |
ClinicalTrials.gov processed this record on March 03, 2013