HIV Accelerated Liver Disease in Uganda
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01524562 |
Recruitment Status
:
Completed
First Posted
: February 2, 2012
Last Update Posted
: April 5, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease |
---|
Fibrosis |
Study Type : | Observational |
Actual Enrollment : | 786 participants |
Time Perspective: | Other |
Official Title: | HIV-Accelerated Liver Disease in Uganda |
Study Start Date : | December 20, 2011 |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
-
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524562
United States, Maryland | |
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Steven J Reynolds, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT01524562 History of Changes |
Other Study ID Numbers: |
999912037 12-I-N037 |
First Posted: | February 2, 2012 Key Record Dates |
Last Update Posted: | April 5, 2018 |
Last Verified: | March 6, 2018 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Fibrosis Cirrhosis Africa |
Schistosomiasis Aflatoxin Liver Disease |
Additional relevant MeSH terms:
Fibrosis Liver Diseases Pathologic Processes Digestive System Diseases |