Acute Hepatitis CNCT00959166
To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection
A study testing PET scan in people with Acute Hepatitis C and HIV, run by Imperial College London at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Hepatitis C, HIV, HIV Infections
- What is being tested?
- PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Male
- Abbreviated Mental Test Score of at least 8/10
Who cannot join
- 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
Show all 13Show fewer
- Established dementia
- Alcohol dependence or recreational drug misuse
- Untreated early syphilis
- Hepatitis B infection (HBsAg positive)
- Pregnancy
- Unable to give informed consent
- Any contraindication to MR scanning
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Acute Hepatitis C, HIV, HIV Infections
- Being tested
- PET scan
- Keywords
- Acute hepatitis C, HIV, Neurocognitive function, Neuroinflammation
- Medical subject headings
- HIV Infections, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanOther
PET brain scan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PET scan |
| HIV mono | Other | HIV-infected individuals without hepatitis C co-infection Receives: Other: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Hepatitis CStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Winston, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959166
- Sponsor's protocol ID
- 09/H0712/17
- Status last verified
- Oct 2019
- First submitted
- 13 Aug 2009
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22808022
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00959166
- Acronym / sponsor ID
- 09/H0712/17
- Conditions
- Acute Hepatitis C, HIV, HIV Infections
- Keywords
- Acute hepatitis C, HIV, Neurocognitive function, Neuroinflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV/acute HCV coinfection | Other | Other: PET scanSubjects 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 | Other: PET scanHIV-infected individuals without hepatitis C co-infection |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scanPET brain scan | Other | HIV mono, HIV/acute HCV coinfection |
Primary outcome
Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection
Time frame: 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.
1 secondary outcome
Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22808022Garvey 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.
- Individual participant dataSharing planned: No
Related trials for Acute Hepatitis C
RecruitingObservational study
Proteogenomic Monitoring and Assessment of Liver Transplant Recipients
Liver Transplant, Hepatitis C
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Winston principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET scan in people with Acute Hepatitis C and HIV, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.