Status:
COMPLETED
Physiologic Growth Hormone Effects in HIV Lipodystrophy
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
AIDS
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00100698
Start Date
January 1 2004
End Date
April 1 2009
Last Update
July 27 2010
Active Locations (1)
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1
MGH
Boston, Massachusetts, United States, 02114