Effects of Growth Hormone Releasing Hormone in HIV
|ClinicalTrials.gov Identifier: NCT01263717|
Recruitment Status : Completed
First Posted : December 21, 2010
Results First Posted : October 13, 2014
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Lipodystrophy||Drug: tesamorelin Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV Lipodystrophy|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Tesamorelin (growth hormone releasing hormone) 2mg daily given by subcutaneous injection x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Other Name: Egrifta, growth hormone releasing hormone, TH9507
Placebo Comparator: Placebo (inactive injection)
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Placebo 2mg daily given by subcutaneous injection for the first 6 months of the study, followed by an open-label phase of 6 months of tesamorelin (growth hormone releasing hormone) treatment, 2mg daily given by subcutaneous injection
- Liver Fat [ Time Frame: 6 months ]Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).
- Visceral Adipose Tissue [ Time Frame: 6 months ]Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.
- Intramyocellular Lipid [ Time Frame: 6 months ]Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.
- Endogenous Growth Hormone Secretion [ Time Frame: 6 months ]Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.
- Insulin Sensitivity [ Time Frame: 6 months ]In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.
- HbA1c [ Time Frame: 6 months ]Hemoglobin A1c.
- Insulin Like Growth Factor 1 (IGF-I) [ Time Frame: 6 months ]Insulin Like Growth Factor 1 (IGF-I).
- Lipid Panel [ Time Frame: 6 months ]Fasting lipids. Triglyceride value is given.
- Carotid Intimal Medial Thickness (cIMT) [ Time Frame: 6 months ]Carotid Intimal Medial Thickness (cIMT).
- Glucose Tolerance [ Time Frame: 6 months ]Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.
- Adiponectin [ Time Frame: 6 months ]adiponectin.
- Hemostatic Markers [ Time Frame: 6 months ]Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263717
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven Grinspoon, MD||Massachusetts General Hospital|