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To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

Primary Purpose

Acute Hepatitis C, HIV, HIV Infections

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

PET scan

About this trial

This is an interventional other trial for Acute Hepatitis C focused on measuring Acute hepatitis C, HIV, Neurocognitive function, Neuroinflammation

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

St Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

HIV/acute HCV coinfection

HIV mono

Arm Description

Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.

HIV-infected individuals without hepatitis C co-infection

Outcomes

Primary Outcome Measures

Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection

Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.

Secondary Outcome Measures

Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites

Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios. By quantifying the surrogate markers of N-acetylaspartate (NAA), creatine (Cr) offers insight into the neuronal integrity, cell membrane synthesis and turnover, macrophage infiltration, inflammation status, and levels of microglial activation and gliosis within the sampled CNS tissue.

Full Information

NCT ID

NCT00959166

First Posted

August 13, 2009

Last Updated

October 21, 2019

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT00959166

Brief Title

To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

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 Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 2009 (Actual)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Hepatitis C, HIV, HIV Infections

Keywords

Acute hepatitis C, HIV, Neurocognitive function, Neuroinflammation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIV/acute HCV coinfection

Arm Type

Other

Arm Description

Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.

Arm Title

HIV mono

Arm Type

Other

Arm Description

HIV-infected individuals without hepatitis C co-infection

Intervention Type

Other

Intervention Name(s)

PET scan

Intervention Description

PET brain scan

Primary Outcome Measure Information:

Title

Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites

Description

Time Frame

30 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Winston

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Mary's Hospital

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22808022

Citation

Garvey LJ, Pavese N, Ramlackhansingh A, Thomson E, Allsop JM, Politis M, Kulasegaram R, Main J, Brooks DJ, Taylor-Robinson SD, Winston A. Acute HCV/HIV coinfection is associated with cognitive dysfunction and cerebral metabolite disturbance, but not increased microglial cell activation. PLoS One. 2012;7(7):e38980. doi: 10.1371/journal.pone.0038980. Epub 2012 Jul 12.

Results Reference

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To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

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