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

NCT ID: NCT00795210

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-11-30

Brief Summary

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.

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.

Conditions

HIV Lipodystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GH 6mcg/kg/d

Recombinant human growth hormone 6mcg/kg SC once daily

Group Type: EXPERIMENTAL

Growth hormone

Intervention Type: DRUG

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

GH 2mg daily

Recombinant human growth hormone 2mg SC once daily

Group Type: EXPERIMENTAL

Growth hormone

Intervention Type: DRUG

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

Growth Hormone Releasing Hormone

Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks

Group Type: EXPERIMENTAL

Growth Hormone Releasing Hormone

Intervention Type: DRUG

Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Interventions

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

Intervention Type: DRUG

Growth Hormone Releasing Hormone

Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Intervention Type: DRUG

Other Intervention Names

rhGH from Teva Pharmaceuticals

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven K. Grinspoon, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven K Grinspoon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

MGH

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01DK063639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK63639A

Identifier Type: -

Identifier Source: org_study_id