Tesamorelin Effects on Liver Fat and Histology in HIV
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|ClinicalTrials.gov Identifier: NCT02196831|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2014
Last Update Posted : March 11, 2019
Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis.
NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals with increased visceral adiposity generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous study, treatment with tesamorelin in HIV-infected individuals selected for abdominal adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus (HIV) Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis (NASH)||Drug: tesamorelin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Tesamorelin Effects on Liver Fat and Histology in HIV: A Collaborative UO1 Grant|
|Actual Study Start Date :||July 1, 2015|
|Actual Primary Completion Date :||January 16, 2019|
|Estimated Study Completion Date :||July 2019|
tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.
Other Name: Egrifta
Placebo Comparator: Placebo
placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.
inactive substance that looks like tesamorelin
- Liver fat as measured by 1-H Magnetic resonance spectroscopy [ Time Frame: 12 months ]
- Nonalcoholic fatty liver disease activity score [ Time Frame: 12 months ]
- alanine aminotransferase (ALT) [ Time Frame: 12 months ]
- aspartate aminotransferase (AST) [ Time Frame: 12 months ]
- liver stiffness measured by FibroScan [ Time Frame: 12 months ]
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): NCT02196831
|United States, Maryland|
|National Institutes of Health|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven K Grinspoon, MD||MGH|