Effects of Growth Hormone Releasing Hormone in HIV
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Endocrine |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/1/2017 |
| Start Date: | December 2010 |
| End Date: | February 2014 |
Effects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV Lipodystrophy
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 often have decreased growth hormone (GH) levels. Low GH levels may
contribute independently to increased belly fat and to increased cardiovascular risk through
effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth
hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients
with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat
accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet
known. The current study is designed to determine the effects of tesamorelin treatment on fat
accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers
of cardiovascular health including blood vessel thickness (carotid intima media thickness
[cIMT]) and markers of inflammation in the body. The investigators hypothesize that
tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers
of inflammation, with either neutral or beneficial effects on glucose metabolism.
as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and
increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may
contribute independently to increased belly fat and to increased cardiovascular risk through
effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth
hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients
with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat
accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet
known. The current study is designed to determine the effects of tesamorelin treatment on fat
accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers
of cardiovascular health including blood vessel thickness (carotid intima media thickness
[cIMT]) and markers of inflammation in the body. The investigators hypothesize that
tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers
of inflammation, with either neutral or beneficial effects on glucose metabolism.
Inclusion Criteria:
1. Men and women age 18-65
2. Previously diagnosed HIV infection
3. Stable antiviral regimen for at least 12 weeks prior to enrollment
4. 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
5. 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
6. For female subjects 40yo or older, negative mammogram within one year of baseline
Exclusion Criteria:
1. 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.
2. Use of GH or GHRH within the past 6 months
3. Change in lipid lowering or antihypertensive regimen within 3 months of screening
4. Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, HgB < 12.0 g/dL, creatinine >
1.4 mg/dL, CD4 count < 200
5. Severe chronic illness or active malignancy or history of pituitary malignancy or
history of colon cancer
6. For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5
ng/mL
7. Prior history of hypopituitarism, head irradiation or any other condition known to
affect the GH axis
8. For women, positive urine hCG
9. Oral contraceptives, depo provera or combined progesterone-estrogen injections,
transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months
of the study.
10. Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral
aneurysm clip.
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