HIV Accelerated Liver Disease in Uganda

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.

• Salmon-Ceron D, Lewden C, Morlat P, Bévilacqua S, Jougla E, Bonnet F, Héripret L, Costagliola D, May T, Chêne G; Mortality 2000 study group. Liver disease as a major cause of death among HIV infected patients: role of hepatitis C and B viruses and alcohol. J Hepatol. 2005 Jun;42(6):799-805.
• Soriano V, Martín-Carbonero L, García-Samaniego J, Puoti M. Mortality due to chronic viral liver disease among patients infected with human immunodeficiency virus. Clin Infect Dis. 2001 Nov 15;33(10):1793-5.
• Lewden C, Salmon D, Morlat P, Bévilacqua S, Jougla E, Bonnet F, Héripret L, Costagliola D, May T, Chêne G; Mortality 2000 study group. Causes of death among human immunodeficiency virus (HIV)-infected adults in the era of potent antiretroviral therapy: emerging role of hepatitis and cancers, persistent role of AIDS. Int J Epidemiol. 2005 Feb;34(1):121-30. Epub 2004 Nov 23.

• INCLUSION CRITERIA:

  1. Adults aged 18 and older
  2. Persons who are able and willing to provide informed consent

  3. Persons who have a transient elastography score >=9.0 kPa or have other evidence of liver disease, and who are willing to undergo an ultrasound and liver biopsy

     i) Other evidence of liver disease: Persons with an LSM <9.0 kPa who demonstrate liver transaminases at least 2-times greater than the upper limit of normal; those with persistently abnormal liver

     transaminases over a period of three months during the year preceding enrollment; those who show abnormalities on their ultrasound; those with other laboratory tests indicating the possibility of liver disease; and/or those who have a clinical or medical indication for a liver biopsy.

  4. Persons who are willing to have tissue samples undergo genetic testing
  5. Persons who agree to have samples stored for the purpose of future research

EXCLUSION CRITERIA:

1. Women who are pregnant
2. Persons with a cardiac device (i.e., pacemaker)
3. Participants who are not able to follow study instructions
4. 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).
5. Evidence of decompensated liver disease including ascites, or hepatic encephalopathy
6. Persons who have any condition deemed, by the investigators, to be a contraindication to study participation