Status:
COMPLETED
Effects of Short-term Growth Hormone in HIV-infected Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV Lipodystrophy
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00795210
Start Date
February 1 2009
End Date
November 1 2012
Last Update
January 8 2014
Active Locations (1)
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1
MGH
Boston, Massachusetts, United States, 02114