HIV InfectionsNCT03599882
Liver Steatosis and Stiffness in HIV
An observational study of HIV Infections and Fatty Liver, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: With the advances in treatment and clinical care, individuals with human immunodeficiency virus (HIV) infection have experienced an increase in life expectancy. Liver disease is common among HIV-infected patients due to the shared routes of transmission of HIV and viral hepatitis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- HIV Infections, Fatty Liver, Liver Fibroses
- What is being tested?
- Fibroscan
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 31 Jul 2019
- How long will I take part?
- 2 Years
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HIV infection
Who may be able to join
- Age: 20-65 years
- Males and females with HIV infection diagnosed by infection doctors
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Who cannot join
- Pregnancy
- Unable to complete the noninvasive procedure of VCTE and CAP
- Unwilling to provide written informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Yi-Cheng Chen, MD, 886-3-3281200 ext. 8107, yichengliver@gmail.com
Chun-Wen Cheng, MD
About this study
Official title: Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography
Background:
With the advances in treatment and clinical care, individuals with human immunodeficiency virus (HIV) infection have experienced an increase in life expectancy. Liver disease is common among HIV-infected patients due to the shared routes of transmission of HIV and viral hepatitis. Nonalcoholic fatty liver disease (NAFLD) is the most common cause of elevated aminotransferases in HIV-monoinfected adults without HBV or HCV.
Read more
Vibration-controlled transient elastography (VCTE) has been shown to have good sensitivity and specificity for assessment of liver fibrosis in HIV and viral hepatitis coinfected patients, as well as in HIV-negative NASH population. Controlled attenuation parameter (CAP), a novel physical parameter developed using the postulate that fat affects ultrasound propagation, measures the ultrasound attenuation at the center frequency of the FibroScan®.
Study design:
This is a prospective observational study.
Objective:
The aim of this study is to evaluate the liver steatosis and fibrosis in HIV-infected patients by noninvasive methods of VCTE and CAP.
Methods:
Patient number: 200
Inclusion criteria:
- Age: 20-65 years
- Males and females with HIV infection diagnosed by infection doctors
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
- Pregnancy
- Unable to complete the noninvasive procedure of VCTE and CAP
- Unwilling to provide written informed consent to participate in the study
- Conditions
- HIV Infections, Fatty Liver, Liver Fibroses
- Being tested
- Fibroscan
- Keywords
- human immunodeficiency virus, liver steatosis, liver fibrosis, controlled attenuation parameter, transient elastography
- Medical subject headings
- HIV Infections, Fatty Liver, Liver Cirrhosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDevice
Fibroscan with controlled attenuation parameter and transient elastography
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of liver steatosis in HIV-infected patients by FibroScan (CAP)
The liver steatosis will be evaluated by controlled attenuation parameter at 6-month interval. The overtime changes will be explored.
Measured: 2 years
The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE)
The liver fibrosis will be assessed by transient elastography at 6-month interval. The overtime changes will be explored.
Measured: 2 years
Secondary outcomes (3)
The association between FIB-4 and liver fibrosis
FIB-4 will be calculated by a formula. FIB-4=[age(year)*AST(U/L)]/[platelet count*ALT(U/L)^0.5]
Measured: 2 years
The association between BMI and liver steatosis
BMI is combination of BW and BH and presented as kg/m^2.
Measured: 2 years
The association between lipid profile and liver steatosis
Lipid profile includes cholesterol, triglyceride, HDL cholesterol, LDL cholesterol.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Cheng Chen, Chang Gung Memorial Hospital
- Investigators
- Yi-Cheng Chen, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599882
- Sponsor's protocol ID
- HIV-LSM-CAP
- Status last verified
- Aug 2018
- First submitted
- 4 Jul 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography
- ClinicalTrials.gov ID
- NCT03599882
- Acronym / sponsor ID
- HIV-LSM-CAP
- Conditions
- HIV Infections, Fatty Liver, Liver Fibroses
- Keywords
- human immunodeficiency virus, liver steatosis, liver fibrosis, controlled attenuation parameter, transient elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- 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.
Background:
With the advances in treatment and clinical care, individuals with human immunodeficiency virus (HIV) infection have experienced an increase in life expectancy. Liver disease is common among HIV-infected patients due to the shared routes of transmission of HIV and viral hepatitis. Nonalcoholic fatty liver disease (NAFLD) is the most common cause of elevated aminotransferases in HIV-monoinfected adults without HBV or HCV.
Vibration-controlled transient elastography (VCTE) has been shown to have good sensitivity and specificity for assessment of liver fibrosis in HIV and viral hepatitis coinfected patients, as well as in HIV-negative NASH population. Controlled attenuation parameter (CAP), a novel physical parameter developed using the postulate that fat affects ultrasound propagation, measures the ultrasound attenuation at the center frequency of the FibroScan®.
Study design:
This is a prospective observational study.
Objective:
The aim of this study is to evaluate the liver steatosis and fibrosis in HIV-infected patients by noninvasive methods of VCTE and CAP.
Methods:
Patient number: 200
Inclusion criteria:
- Age: 20-65 years
- Males and females with HIV infection diagnosed by infection doctors
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
- Pregnancy
- Unable to complete the noninvasive procedure of VCTE and CAP
- Unwilling to provide written informed consent to participate in the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HIV infection
Key inclusion criteria (4 listed)
- Age: 20-65 years
- Males and females with HIV infection diagnosed by infection doctors
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Key exclusion criteria (3 listed)
- Pregnancy
- Unable to complete the noninvasive procedure of VCTE and CAP
- Unwilling to provide written informed consent to participate in the study
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 |
|---|---|---|
| FibroscanFibroscan with controlled attenuation parameter and transient elastography | Device | – |
Primary outcome
The changes of liver steatosis in HIV-infected patients by FibroScan (CAP)
Time frame: 2 years
The liver steatosis will be evaluated by controlled attenuation parameter at 6-month interval. The overtime changes will be explored.
The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE)
Time frame: 2 years
The liver fibrosis will be assessed by transient elastography at 6-month interval. The overtime changes will be explored.
3 secondary outcomes
The association between FIB-4 and liver fibrosis
Time frame: 2 years
The association between BMI and liver steatosis
Time frame: 2 years
The association between lipid profile and liver steatosis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Yi-Cheng Chen principal investigator
Chang Gung Memorial Hospital
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 Infections and Fatty Liver, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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 21 Aug 2018. 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 Taiwan. 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?
Contact Yi-Cheng Chen, MD (886-3-3281200 ext. 8107, yichengliver@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of liver steatosis in HIV-infected patients by FibroScan (CAP) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 21 Aug 2018.