Acute Hepatitis C, HIV, HIV Infections
Conditions
Keywords
Acute hepatitis C, HIV, Neurocognitive function, Neuroinflammation
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.
Interventions
OTHERPET scan
PET brain scan
Sponsors
Imperial College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV/Acute HCV Coinfection Subjects with HIV/acute HCV coinfection | 24 |
| HIV Mono HIV-infected individuals without hepatitis C co-infection | 57 |
| Total | 81 |
Baseline characteristics
| Characteristic | HIV/Acute HCV Coinfection | HIV Mono | Total |
|---|---|---|---|
| Age, Continuous | 41 years | 47 years | 44 years |
| Current CD4+ cells | 590 cells/uL | 505 cells/uL | 547 cells/uL |
| Number of participants receiving antiretroviral therapy | 17 Participants | 54 Participants | 71 Participants |
| Plasma HIV viral load below 50c/ml | 16 Participants | 54 Participants | 70 Participants |
| Region of Enrollment United Kingdom | 24 participants | 57 participants | 81 participants |
| Sex: Female, Male Female | 0 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 24 Participants | 50 Participants | 74 Participants |
| Time-elapsed since HIV diagnosis | 6 years | 11 years | 8.5 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 57 |
| other Total, other adverse events | 0 / 24 | 0 / 57 |
| serious Total, serious adverse events | 0 / 24 | 0 / 57 |
Outcome results
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.
Time frame: 30 days
Population: 16 subjects in total had PET scans and were included in the PET outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV/Acute HCV Coinfection | Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection | 0.18 binding potential ratio | Standard Deviation 0.1 |
| HIV Mono | Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection | 0.22 binding potential ratio | Standard Deviation 0.13 |
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.
Time frame: 30 days
Population: 24/12 subjects in each study group had MR spectroscopy and could be included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV/Acute HCV Coinfection | Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites | 1.42 ratio | Standard Deviation 0.25 |
| HIV Mono | Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites | 1.35 ratio | Standard Deviation 0.1 |