Status:
COMPLETED
HIV Accelerated Liver Disease in Uganda
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Fibrosis
Eligibility:
All Genders
18-99 years
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 re...
Detailed Description
With improved survival following the introduction of highly active antiretroviral therapy (HAART), liver disease has become a leading cause of death among HIV-infected persons in Western cohorts, prim...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 20 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2019
Estimated Enrollment :
786 Patients enrolled
Trial Details
Trial ID
NCT01524562
Start Date
December 20 2011
End Date
December 17 2019
Last Update
January 6 2020
Active Locations (1)
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1
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
Bethesda, Maryland, United States, 20892