Status:
COMPLETED
Effects of Growth Hormone Releasing Hormone in HIV
Lead Sponsor:
Massachusetts General Hospital
Conditions:
HIV
HIV Lipodystrophy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat o...
Eligibility Criteria
Inclusion
- Men and women age 18-65
- Previously diagnosed HIV infection
- Stable antiviral regimen for at least 12 weeks prior to enrollment
- WC\>95 cm and WHR\>0.94 for male, WC\>94 cm and WHR\>0.88 for female occurring in the context of treatment for HIV disease
- Subjective evidence of at least one of the following recent 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
- For female subjects 40yo or older, negative mammogram within one year of baseline
Exclusion
- Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study. Stable use of testosterone (\> 6 mos) at dose equivalent to 200 mg IM q 2 weeks or \< 10g/day to skin will be permitted.
- Use of GH or GHRH within the past 6 months
- Change in lipid lowering or antihypertensive regimen within 3 months of screening
- Fasting blood sugar \> 126 mg/dL, SGOT \> 2.5 times ULN, HgB \< 12.0 g/dL, creatinine \> 1.4 mg/dL, CD4 count \< 200
- 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 \> 5 ng/mL
- Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
- For women, positive urine hCG
- Oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study.
- Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01263717
Start Date
December 1 2010
End Date
February 1 2014
Last Update
October 30 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114