Effects of Short-term Growth Hormone in HIV-infected Patients

Condition(s) targeted: HIV Lipodystrophy

Intervention: Growth hormone (Drug); Growth Hormone Releasing Hormone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Steven K Grinspoon, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Official title: Effects of Short-term Growth Hormone in HIV-infected Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug

Secondary outcome: Insulin Sensitivity

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

MGH, Boston, Massachusetts 02114, United States

Starting date: February 2009
Last updated: December 6, 2013