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

Not Applicable

Completed

• Conditions: HIV; HIV Infections; Acute Hepatitis C
• Interventions: Other: PET scan

• Registration Number: NCT00959166
• Lead Sponsor: Imperial College London

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Results First Submitted: 2019-09-24
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-21
• Last Update Submitted: 2019-10-21
• Results First Posted: 2019-10-22
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV/acute HCV coinfection	PET scan	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 mono	PET scan	HIV-infected individuals without hepatitis C co-infection

Primary Outcome Measures

Name	Time	Method
Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection	30 days	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

Name	Time	Method
Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites	30 days	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.

Trial Locations

Locations (1)

St Mary's Hospital; 🇬🇧 London, United Kingdom