- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01524562
HIV Accelerated Liver Disease in Uganda
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Description
INCLUSION CRITERIA:
- 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
EXCLUSION CRITERIA:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Rakai Community Cohort
HIV Patients
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Rakai HIV Care Program
HIV Patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defining the eriology of liver disease
Time Frame: 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.
|
2 years
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999912037
- 12-I-N037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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