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

Imperial College London

Status: Completed

Conditions: HIV; Acute Hepatitis C; HIV Infections

Treatments: Other: PET scan

Study type: Interventional

Funder types: Other

Identifiers

NCT00959166

09/H0712/17

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: Male

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

HIV/acute HCV coinfection

Other group

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.

Treatment:

Other: PET scan

HIV mono

Other group

Description:

HIV-infected individuals without hepatitis C co-infection

Treatment:

Other: PET scan