Clinical trial NCT00959166: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Hepatitis C
HIV
HIV Infections
Keywords: Acute hepatitis C
HIV
Neurocognitive function
Neuroinflammation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 81
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection
timeFrame: 30 days
Secondary outcomes:
measure: Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: Imperial College London
name: Alan Winston
role: PRINCIPAL_INVESTIGATOR
References:
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.