HIV Accelerated Liver Disease in Uganda

Completed

• Conditions: Fibrosis

• Registration Number: NCT01524562
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Background:

- Liver disease is a leading cause of death in people who have the human immunodeficiency virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most research on HIV-related liver disease has been conducted in North America and Europe. However, HIV-related liver disease in Uganda and other African nations may involve other diseases that are not common in the West, and may not involve hepatitis B or C. Researchers want to study HIV-related liver disease in Uganda to learn more about the differences between Western and African trends of this disease.

Objectives:

- To study HIV-related liver disease in rural Uganda.

Eligibility:

* Individuals at least 18 years of age who were tested for possible liver disease. Some participants will have HIV infection; others will be uninfected.

* All participants will be from rural areas of Uganda.

Design:

* Participants will have at least two study visits.

* Participants will have a physical exam and medical history. They will complete a questionnaire about health and quality of life. Blood, urine, and stool samples will be collected. Participants will also have a liver scan to check for liver scarring, and an ultrasound to take images of the liver.

* Participants who may have liver disease will visit a local hospital for more tests. A liver biopsy will be performed to collect liver tissue samples.

Detailed Description

With improved survival following the introduction of highly active antiretroviral therapy (HAART), liver disease has become a leading cause of death among HIV-infected persons in Western cohorts, primarily affecting those co-infected with hepatitis B or C viruses (HBV, HCV). However, data are sparse on liver disease in HIV-infected populations from Uganda and other African nations, where the etiologies of liver disease are broader and include aflatoxin, schistosomiasis and other infectious and environmental agents. Our previous noninvasive study in rural, Rakai, Uganda indicates that the prevalence of significant liver fibrosis is high among HIV-infected individuals (17%) and is 50% higher than in HIV-uninfected persons, although the prevalence of viral hepatitis B co-infection is low (5%). The study presented here is a biopsy-based study that follows up on these results with the objectives of defining the etiology of liver disease and describing the mechanisms of HIV-accelerated liver fibrosis in this setting.

Study Timeline

• Study Start: 2011-12-20
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-02
• Primary Completion: 2015-05-12
• Study Completion: 2019-12-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 786

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Defining the eriology of liver disease	2 years	Describe the etiologiges and compare the pathogenesis of liver fibrosis in HIV-infected and HIV-uninfected persons wirh evidence of liver disease in rural, Rakai Uganda.

Trial Locations

Locations (1)

National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi; 🇺🇸 Bethesda, Maryland, United States