HIV/AIDSNCT04446156
Liver Diseases in PLWH
An observational study of HIV/AIDS and Liver Diseases, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
In Highly Active Antiretroviral Therapy era, fatty liver has become an important cause of liver function damage in people living with HIV (PLWH). There are a large number of PLWH in China who are infected with hepatitis B virus and hepatitis C virus. HIV, hepatitis B virus, hepatitis C virus, drugs, alcohol, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Liver Diseases
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2020to 30 Dec 2020
- 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: PLWH crowd in Zhejiang Province
Who may be able to join
- Age ≥18 years old;
- Non-hospitalized patients diagnosed with HIV infection;
- Sign the informed consent voluntarily.
Who cannot join
- Severe active infection requiring parenteral antibiotics or antifungal treatment within 30 days before the assessment;
- Other major chronic diseases that may affect health-related quality of life, such as extrahepatic malignant tumors;
- Psychotic patients, patients with severe cognitive or neurological deficits;
- Women during pregnancy and lactation;
- Those who refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
Yongzheng Guo, MD, +86 13645814389, ggyongzheng08@zju.edu.cn
Biao Zhu, PhD, +86 13906535457, zhubiao1207@zju.edu.cn
About this study
Official title: Epidemiological Investigation of HIV-infected Patients Complicated With Liver Disease in Zhejiang Province
In Highly Active Antiretroviral Therapy era, fatty liver has become an important cause of liver function damage in people living with HIV (PLWH). There are a large number of PLWH in China who are infected with hepatitis B virus and hepatitis C virus. HIV, hepatitis B virus, hepatitis C virus, drugs, alcohol, etc. affect each other, which makes the cause, diagnosis, and treatment of liver function damage in PLWH complicated in China.
The investigators plan to conduct a large-scale questionnaire survey among PLWH in Zhejiang Province to assess liver function, detect liver Injuries early, and analyze HIV, hepatitis B virus, hepatitis C virus, anti-HIV drugs, alcohol and other factors associate with liver injuries in PLWH, to provide basis for the treatment and prevention of liver disease in PLWH in eastern China.
- Conditions
- HIV/AIDS, Liver Diseases
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of liver disease in PLWH
The overall prevalence of liver disease in PLWH and the prevalence of hepatitis B, C, and fatty liver
Measured: 2020-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start26 May 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446156
- Sponsor's protocol ID
- ZJHIVER
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Investigation of HIV-infected Patients Complicated With Liver Disease in Zhejiang Province
- ClinicalTrials.gov ID
- NCT04446156
- Acronym / sponsor ID
- ZJHIVER
- Conditions
- HIV/AIDS, Liver Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 24 Jun 2020 (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.
In Highly Active Antiretroviral Therapy era, fatty liver has become an important cause of liver function damage in people living with HIV (PLWH). There are a large number of PLWH in China who are infected with hepatitis B virus and hepatitis C virus. HIV, hepatitis B virus, hepatitis C virus, drugs, alcohol, etc. affect each other, which makes the cause, diagnosis, and treatment of liver function damage in PLWH complicated in China.
The investigators plan to conduct a large-scale questionnaire survey among PLWH in Zhejiang Province to assess liver function, detect liver Injuries early, and analyze HIV, hepatitis B virus, hepatitis C virus, anti-HIV drugs, alcohol and other factors associate with liver injuries in PLWH, to provide basis for the treatment and prevention of liver disease in PLWH in eastern China.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PLWH crowd in Zhejiang Province
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- Non-hospitalized patients diagnosed with HIV infection;
- Sign the informed consent voluntarily.
Key exclusion criteria (5 listed)
- Severe active infection requiring parenteral antibiotics or antifungal treatment within 30 days before the assessment;
- Other major chronic diseases that may affect health-related quality of life, such as extrahepatic malignant tumors;
- Psychotic patients, patients with severe cognitive or neurological deficits;
- Women during pregnancy and lactation;
- Those who refuse to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of liver disease in PLWH
Time frame: 2020-12-31
The overall prevalence of liver disease in PLWH and the prevalence of hepatitis B, C, and fatty liver
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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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.
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/AIDS and Liver Diseases, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 3 inclusion and 5 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 30 Jun 2020. 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 China. 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 Biao Zhu, PhD. (+86 13906535457, zhubiao1207@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of liver disease in PLWH (time frame: 2020-12-31). 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 30 Jun 2020.