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

NCT00795210 | Completed Results

• 2 other identifiers: DK63639AR01DK063639
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Lipodystrophy

Keywords

HIV lipodystrophy; growth hormone; growth hormone releasing hormone

Outcome Measures

Primary Outcomes (1)

• Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug

  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.

  after 2 weeks treatment

Secondary Outcomes (1)

• Insulin Sensitivity

  after two weeks treatment

Study Arms (3)

GH 6mcg/kg/d

EXPERIMENTAL

Recombinant human growth hormone 6mcg/kg SC once daily

Drug: Growth hormone

GH 2mg daily

EXPERIMENTAL

Recombinant human growth hormone 2mg SC once daily

Drug: Growth hormone

Growth Hormone Releasing Hormone

EXPERIMENTAL

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

Drug: Growth Hormone Releasing Hormone

Interventions

Growth hormone 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

Also known as: rhGH from Teva Pharmaceuticals

GH 2mg daily; GH 6mcg/kg/d

Growth Hormone Releasing Hormone DRUG

Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Growth Hormone Releasing Hormone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Growth Hormone; Growth Hormone-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

The study was completed early due to the lack of availability of study drug for one of the arms.

Results Point of Contact

• Title: Steven Grinspoon, MD
• Organization: Massachusetts General Hospital

sgrinspoon@partners.org

617-724-9109

Study Officials

• Steven K Grinspoon, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: February 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 8, 2014
• Results First Posted: January 8, 2014

Record last verified: 2013-10

Locations

US (1)