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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:
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:
A computer game test which measures brain function
2 short questionnaires
Results of these tests will be analyzed and compared between 3 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV/acute HCV coinfection | Other | 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. |
|
| HIV mono | Other | HIV-infected individuals without hepatitis C co-infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET scan | Other | PET brain scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Winston | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mary's Hospital | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22808022 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV/Acute HCV Coinfection | Subjects with HIV/acute HCV coinfection |
| FG001 | HIV Mono | HIV-infected individuals without hepatitis C co-infection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV/Acute HCV Coinfection | Subjects with HIV/acute HCV coinfection |
| BG001 | HIV Mono | HIV-infected individuals without hepatitis C co-infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 16 subjects in total had PET scans and were included in the PET outcome | Posted | Mean | Standard Deviation | binding potential ratio | 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV/Acute HCV Coinfection | Subjects with HIV/acute HCV coinfection | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Alan Winston | Imperial College London | +44 (0)20 3312 1603 | a.winston@imperial.ac.uk |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 30 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time-elapsed since HIV diagnosis | Median | Inter-Quartile Range | years |
|
| Current CD4+ cells | Median | Inter-Quartile Range | cells/uL |
|
| Number of participants receiving antiretroviral therapy | Count of Participants | Participants |
|
| Plasma HIV viral load below 50c/ml | Count of Participants | Participants |
|
| HIV Mono |
HIV-infected individuals without hepatitis C co-infection |
|
|
| 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. | 24/12 subjects in each study group had MR spectroscopy and could be included in this analysis | Posted | Mean | Standard Deviation | ratio | 30 days |
|
|
|
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | HIV Mono | HIV-infected individuals without hepatitis C co-infection | 0 | 57 | 0 | 57 | 0 | 57 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |