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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 13, 2009

Last Updated Date

May 25, 2010

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00959166 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

HIV positive men with acute HCV infection

Condition ^ICMJE

Acute Hepatitis C
HIV
HIV Infections

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

1
HIV positive men with acute HCV infection
2
HIV positive men who do not have acute HCV
3
Healthy controls

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

25 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00959166

Other Study ID Numbers ^ICMJE

09/H0712/17

Has Data Monitoring Committee

Responsible Party

Dr Alan Winston, Imperial College, London

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alan Winston

Imperial College London

Information Provided By

Imperial College London

Verification Date

May 2010

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

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