Effects of Short-term Growth Hormone in HIV-infected Patients
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ClinicalTrials.gov Identifier: NCT00795210 |
Recruitment Status :
Completed
First Posted : November 21, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Lipodystrophy | Drug: Growth hormone Drug: Growth Hormone Releasing Hormone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Short-term Growth Hormone in HIV-infected Patients |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: GH 6mcg/kg/d
Recombinant human growth hormone 6mcg/kg SC once daily
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Drug: Growth hormone
Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks
Other Name: rhGH from Teva Pharmaceuticals |
Experimental: GH 2mg daily
Recombinant human growth hormone 2mg SC once daily
|
Drug: Growth hormone
Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks
Other Name: rhGH from Teva Pharmaceuticals |
Experimental: Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
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Drug: Growth Hormone Releasing Hormone
Tesamorelin (GHRH) 2mg SC QD x 2 weeks |
- Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug [ Time Frame: after 2 weeks treatment ]Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.
- Insulin Sensitivity [ Time Frame: after two weeks treatment ]insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; "M" value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- previously diagnosed HIV infection
- Stable antiretroviral regimen for at least 12 weeks prior to enrollment
- Waist circumference >/= 95cm and waist-to-hip ratio >/= 0.94 for males or waist circumference >/=94cm and WHR >/= 0.88 for females, occurring in the context of treatment for HIV disease
- Subjective evidence of at least one of the following 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
Exclusion Criteria:
- Use of anti-diabetic agents, Megace, testosterone, or any steroid use within 6 months of the study
- Use of GH or Growth hormone releasing factor within six months of starting the study
- Change in lipid lowering or antihypertensive regimen within 3 months of screening
- Fasting blood sugar >126mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL, FSH > 20 IU/L in women, or CD4 count < 200
- Carpal tunnel syndrome
- Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
- For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5ng/mL
- Prior history of hypopituitarism, head irradiation, or any other condition known to affect the GH axis
- positive beta-HCG (women only)
- Oral contraceptives, depo provera, or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study
- weight < 110 pounds

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): NCT00795210
United States, Massachusetts | |
MGH | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven K Grinspoon, M.D. | Massachusetts General Hospital |
Responsible Party: | Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00795210 |
Other Study ID Numbers: |
DK63639A R01DK063639 ( U.S. NIH Grant/Contract ) |
First Posted: | November 21, 2008 Key Record Dates |
Results First Posted: | January 8, 2014 |
Last Update Posted: | January 8, 2014 |
Last Verified: | October 2013 |
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