Physiologic Growth Hormone Effects in HIV Lipodystrophy
Completed · Not applicable · Has a placebo group
Conditions studied: AIDS, HIV Infections
In brief
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.
Key facts
- Study ID
- NCT00100698
- Run by
- Massachusetts General Hospital
- People needed
- 56
- Starts
- 2004-01-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2010-07-27
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women age 18-60
- Previously diagnosed HIV infection
- Stable antiviral regimen for at least 12 weeks prior to enrollment
- Waist-to-hip ratio >0.90 for men and >0.85 for women
- Evidence of at least one of the following recent changes: *increased abdominal girth,
- relative loss of fat in the extremities, *relative loss of fat in the face
- Simulated peak GH response to arginine/GHRH of less than 7.5 mcg/dL
You may not qualify if…
- Use of Megace, anti-diabetic agents, GH, or other anabolic agents, pharmacologic glucocorticoid (prednisone >5 mg/day or its equivalent) for 3 months prior to enrollment. Patients on a standard dose of testosterone for documented hypogonadism will be allowed to enter the protocol. Women taking standard estrogen replacement therapy for >3 months will be allowed in the study.
- Diabetes mellitus
- Other severe chronic illness
- HgB <9.0 g/dL, creatinine >1.4 mg/dL, or PSA >4 ng/mL
- Positive BHCG or failure to use appropriate birth control during study. Acceptable methods include oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, IUD's, barrier devices (condoms, diaphragms), and abstinence.
- Carpal tunnel syndrome
- Active malignancy or history of pituitary malignancy, history of colon cancer or prostate malignancy
Where it is running
- MGH — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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