Effects of Growth Hormone Releasing Hormone in HIV
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|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.
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): NCT01263717
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven Grinspoon, MD||Massachusetts General Hospital|