NAFLD in HIV-infected Patients (NAFLDIH)

The Epidemiological Investigation and Pathogenesis of NAFLD in HIV-infected Patients: a Cross-sectional Study

The prevalence of NAFLD (nonalcoholic fatty liver disease) in HIV-infected patients is higher than that in general population, but the causes of morbidity and pathogenesis have not been fully explored. The investigators are planning to consecutively enroll 400 cases HIV-positive outpatients, and to detect NAFLD by ultrasound. The fecal and blood samples were also collected to explore the mechanism of NAFLD. The investigators aimed to determine the prevalence and risk factors of NAFLD in HIV infected patients.

Study Overview

• Status: Unknown
• Conditions: NAFLD; HIV-infection/Aids
• Intervention / Treatment: Other: No intervention; cross-sectional study

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Recruiting
      • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected outpatients who was not coinfected with other form of viral hepatitis or drug induced liver disease, some severe systematic disease

Description

Inclusion Criteria:

• Age 18~70 y;
• HIV-positive patients;
• written the informed consent

Exclusion Criteria:

• coinfected with HBV, HCV;
• secondary causes of fatty liver (eg, consumption of amiodarone and tamoxifen) and decompensated liver disease;
• significant alcohol consumption (>20 g per day for man, >10 g per day for woman);
• received antibiotics in preceding two months;
• autoimmune disease;
• severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
• pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV-monoinfected outpatients; No intervention; cross-sectional study	Other: No intervention; cross-sectional study; No intervention; cross-sectional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidity of nonalcoholic fatty liver disease	NAFLD was diagnosed using ultrasound	1 month

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: December 29, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: NAFLD; HIV infection
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Liver Diseases; Slow Virus Diseases; Fatty Liver; HIV Infections; Non-alcoholic Fatty Liver Disease; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20191126V2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No