Liver Steatosis and Stiffness in HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

1. Age: 20-65 years
2. Males and females with HIV infection diagnosed by infection doctors
3. Willing and able to comply with the study requirements
4. Willing and able to provide written informed consent to participate in the study

Exclusion criteria:

1. Pregnancy
2. Unable to complete the noninvasive procedure of VCTE and CAP
3. Unwilling to provide written informed consent to participate in the study

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease

NCT05330923

Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Fibrosis +1 more

RECRUITING

Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy

NCT00326482

Liver Fibrosis Steatohepatitis Elevated Transaminases

COMPLETED

Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons

NCT00889577

HIV Infections Coronary Artery Disease Non-Alcoholic Fatty Liver Disease

COMPLETED

Incidence of Liver Disease-Related Outcomes in People With HIV

NCT06940375

MAFLD Liver Fibrosis MASH +3 more

RECRUITING

Prevalence of Advanced Fibrosis in Patients Living With HIV

NCT04066608

Fatty Liver Disease

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Fatty Liver Liver Fibroses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fibroscan

Fibroscan with controlled attenuation parameter and transient elastography

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age: 20-65 years
2. Males and females with HIV infection diagnosed by infection doctors
3. Willing and able to comply with the study requirements
4. Willing and able to provide written informed consent to participate in the study

Exclusion Criteria

1. Pregnancy
2. Unable to complete the noninvasive procedure of VCTE and CAP
3. Unwilling to provide written informed consent to participate in the study

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No