HIV Infection and Chronic Alanine Aminotransferase ElevationNCT01208376
Prevalence of Liver Fibrosis and Progression of Liver Fibrosis
An observational study of HIV Infection and Chronic Alanine Aminotransferase Elevation, run by Helen Kovari-Kramer at 1 site in Switzerland.
Trial summary
Little is known about the clinical significance of chronic alanine aminotransferase (ALT) elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with chronic ALT elevation and no chronic viral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection and Chronic Alanine Aminotransferase Elevation
- What is being tested?
- Fibroscan
- How many people
- 195 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2010to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation
Who may be able to join
- HIV-1 infection
- no hepatitis B and C coinfection
- chronic alanine aminotransferase (ALT) elevation after 1.1.2007
- signed informed consent
- no other common cause of liver disease
- Control patients:
Show all 10Show fewer
- HIV-infection
- no hepatitis B and C coinfection
- no ALT elevation after 1.1.2002, the date when ALT values were regularly collected in the Swiss HIV Cohort Study (SHCS)
- no known chronic liver disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Liver Fibrosis and Progression of Liver Fibrosis in HIV-infected, Hepatitis C (HCV) and Hepatitis B (HBV) Seronegative Patients With Chronic Alanine Aminotransferase (ALT) Elevation
Little is known about the clinical significance of chronic alanine aminotransferase (ALT) elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and second to find associated factors with significant fibrosis and cirrhosis. In a second longitudinal part we intend to assess fibrosis progression within 1 and 3 years.
- Being tested
- Fibroscan
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanOther
Also called Fibroscan and Serum Fibrose-marker
Fibroscan and Serum Fibrose-marker
| Study group | Role | What they receive |
|---|---|---|
| unexplained chronic ALT elevation | Case patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation Receives: Other: Fibroscan | |
| always normal ALT | Control patients: HIV-infected, always normal ALT values Receives: Other: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liverfibrosis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infection and Chronic Alanine Aminotransferase ElevationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Kovari-Kramer
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss HIV Cohort Study
- Responsible party
- Sponsor-investigator, Helen Kovari-Kramer, University of Zurich
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208376
- Sponsor's protocol ID
- SHCS 625
- Status last verified
- May 2016
- First submitted
- 22 Sep 2010
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Liver Fibrosis and Progression of Liver Fibrosis in HIV-infected, Hepatitis C (HCV) and Hepatitis B (HBV) Seronegative Patients With Chronic Alanine Aminotransferase (ALT) Elevation
- ClinicalTrials.gov ID
- NCT01208376
- Acronym / sponsor ID
- SHCS 625
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Helen Kovari-KramerUniversity, hospital or other
- Collaborators
- Swiss HIV Cohort Study
- Study start
- Oct 2010
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Little is known about the clinical significance of chronic alanine aminotransferase (ALT) elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and second to find associated factors with significant fibrosis and cirrhosis. In a second longitudinal part we intend to assess fibrosis progression within 1 and 3 years.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unexplained chronic ALT elevation | – | Other: FibroscanCase patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation |
| always normal ALT | – | Other: FibroscanControl patients: HIV-infected, always normal ALT values |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation
Key inclusion criteria (10 listed)
- HIV-1 infection
- no hepatitis B and C coinfection
- chronic alanine aminotransferase (ALT) elevation after 1.1.2007
- signed informed consent
- no other common cause of liver disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FibroscanAlso: Fibroscan and Serum Fibrose-markerFibroscan and Serum Fibrose-marker | Other | always normal ALT, unexplained chronic ALT elevation |
Primary outcome
Liverfibrosis
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Chronic Alanine Aminotransferase Elevation, run by Helen Kovari-Kramer at 1 site in Switzerland.
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 10 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 20 Dec 2016. 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 Switzerland. 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?
Results are not available in the source record.
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?
Liverfibrosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2016.