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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
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness [cIMT]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism.

Condition or disease Intervention/treatment Phase
HIV HIV Lipodystrophy Drug: tesamorelin Drug: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Hormones
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tesamorelin
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
 Drug: tesamorelin
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
 Drug: placebo
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. HbA1c [ Time Frame: 6 months ]
    Hemoglobin A1c.

  5. Insulin Like Growth Factor 1 (IGF-I) [ Time Frame: 6 months ]
    Insulin Like Growth Factor 1 (IGF-I).

  6. Lipid Panel [ Time Frame: 6 months ]
    Fasting lipids. Triglyceride value is given.

  7. Carotid Intimal Medial Thickness (cIMT) [ Time Frame: 6 months ]
    Carotid Intimal Medial Thickness (cIMT).

  8. Glucose Tolerance [ Time Frame: 6 months ]
    Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.

  9. Adiponectin [ Time Frame: 6 months ]
    adiponectin.

  10. Hemostatic Markers [ Time Frame: 6 months ]
    Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women age 18-65
  2. Previously diagnosed HIV infection
  3. Stable antiviral regimen for at least 12 weeks prior to enrollment
  4. WC>95 cm and WHR>0.94 for male, WC>94 cm and WHR>0.88 for female occurring in the context of treatment for HIV disease
  5. Subjective evidence of at least one of the following recent changes, occurring during the treatment of HIV disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face
  6. For female subjects 40yo or older, negative mammogram within one year of baseline

Exclusion Criteria:

  1. Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study. Stable use of testosterone (> 6 mos) at dose equivalent to 200 mg IM q 2 weeks or < 10g/day to skin will be permitted.
  2. Use of GH or GHRH within the past 6 months
  3. Change in lipid lowering or antihypertensive regimen within 3 months of screening
  4. Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, HgB < 12.0 g/dL, creatinine > 1.4 mg/dL, CD4 count < 200
  5. Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
  6. For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5 ng/mL
  7. Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
  8. For women, positive urine hCG
  9. Oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study.
  10. Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263717     History of Changes
Other Study ID Numbers: 2007p-000638
First Posted: December 21, 2010    Key Record Dates
Results First Posted: October 13, 2014
Last Update Posted: October 30, 2017
Last Verified: September 2017

Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
HIV
lipodystrophy
tesamorelin
Egrifta
growth hormone releasing hormone

Additional relevant MeSH terms:
Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
 Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs