HIV Accelerated Liver Disease in Uganda

NCT01524562 | Completed

• 2 other identifiers: 99991203712-I-N037
• Study Type: observational
• Target: 786
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosis

Keywords

Fibrosis; Cirrhosis; Africa; Schistosomiasis; Aflatoxin; Liver Disease

Outcome Measures

Primary Outcomes (1)

• Defining the eriology of liver disease

  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.

  2 years

Study Arms (2)

Rakai Community Cohort

HIV Patients

Rakai HIV Care Program

HIV Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

You may qualify if:

• Adults aged 18 and older
• Persons who are able and willing to provide informed consent
• 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.
• Persons who are willing to have tissue samples undergo genetic testing
• Persons who agree to have samples stored for the purpose of future research

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Salmon-Ceron D, Lewden C, Morlat P, Bevilacqua S, Jougla E, Bonnet F, Heripret L, Costagliola D, May T, Chene 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. doi: 10.1016/j.jhep.2005.01.022.

  PMID: 15973779 BACKGROUND

• Soriano V, Martin-Carbonero L, Garcia-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. doi: 10.1086/323009. No abstract available.

  PMID: 11641832 BACKGROUND

• Lewden C, Salmon D, Morlat P, Bevilacqua S, Jougla E, Bonnet F, Heripret L, Costagliola D, May T, Chene 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. doi: 10.1093/ije/dyh307. Epub 2004 Nov 23.

  PMID: 15561752 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Schistosomiasis; Liver Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases; Digestive System Diseases

Study Officials

• Steven J Reynolds, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 2, 2012
• Study Start: December 20, 2011
• Primary Completion: May 12, 2015
• Study Completion: December 17, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

US (1)