HIV Accelerated Liver Disease in Uganda

Completed

Conditions studied: Fibrosis

In brief

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.

Key facts

Study ID

NCT01524562

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

786

Starts

2011-12-20

Expected to finish

2019-12-17

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Women who are pregnant
• Persons with a cardiac device (i.e., pacemaker)
• Participants who are not able to follow study instructions
• Safety laboratory data indicating possible excess risk of bleeding including platelets <75,000 and an INR>=1.5. These safety laboratory values will be ascertained by obtaining a Complete Blood Count (CBC) and a Prothrombin Time (PT).
• Evidence of decompensated liver disease including ascites, or hepatic encephalopathy
• Persons who have any condition deemed, by the investigators, to be a contraindication to study participation

Where it is running

• National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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