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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959166
• Other study ID #: 09/H0712/17
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hepatitis C
• Coinfection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV
• HIV Infections
• Infection

Intervention

Other:
• PET scan
PET brain scan

Locations

Country	Name	City	State
United Kingdom	St Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 incre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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.	30 days