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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV-1 antibody positive for at least 12 months
- •Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months)
- •HCV genotype 1
- •Ability to give informed consent
- •Aged > 25 years
- •Abbreviated Mental Test Score of at least 8/10
排除标准
- •Evidence of established cirrhosis or encephalopathy
- •Commencing or any change to HIV medications within 12 weeks
- •Active opportunistic infection
- •Taking anti-depressants or any psychoactive medications within past 4 weeks
- •Use of benzodiazepines within past 4 weeks
- •Recent significant head injury
- •Established dementia
- •Alcohol dependence or recreational drug misuse
- •Untreated early syphilis
- •Hepatitis B infection (HBsAg positive)
- •Unable to give informed consent
- •Any contraindication to MR scanning
研究组 & 干预措施
HIV/acute HCV coinfection
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.
干预措施: PET scan (Other)
HIV mono
HIV-infected individuals without hepatitis C co-infection
干预措施: PET scan (Other)
结局指标
主要结局
Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection
时间窗: 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.
次要结局
- Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites(30 days)