Effects of Short-term Growth Hormone in HIV-infected Patients
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Purpose
The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.
| Condition | Intervention |
|---|---|
|
HIV Lipodystrophy |
Drug: Growth hormone Drug: Growth Hormone Releasing Hormone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Short-term Growth Hormone in HIV-infected Patients |
- Overnight mean growth hormone secretion [ Time Frame: after 2 weeks treatment and 2 weeks withdrawal ] [ Designated as safety issue: No ]
- insulin sensitivity [ Time Frame: after two weeks treatment and two weeks withdrawal ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | February 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GH 6mcg/kg/d
Recombinant human growth hormone 6mcg/kg 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: 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
|
Drug: Growth Hormone Releasing Hormone
Tesamorelin (GHRH) 2mg SC QD x 2 weeks
|
Detailed Description:
The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the treatment and will return for an identical assessment after a 2 week withdrawal period.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Massachusetts | |
| MGH | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Steven K Grinspoon, M.D. | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00795210 History of Changes |
| Other Study ID Numbers: | DK63639A, R01DK063639 |
| Study First Received: | November 20, 2008 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
HIV lipodystrophy growth hormone 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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013