Effects of Growth Hormone Releasing Hormone in HIV

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Brief Title

Effects of Growth Hormone Releasing Hormone in HIV

Official Title

Effects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV Lipodystrophy

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 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.
    



Study Type

Interventional


Primary Outcome

Liver Fat

Secondary Outcome

 Intramyocellular Lipid

Condition

HIV

Intervention

tesamorelin

Study Arms / Comparison Groups

 Tesamorelin
Description:  Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

54

Start Date

December 2010

Completion Date

February 2014

Primary Completion Date

February 2014

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Steven Grinspoon, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01263717

Organization ID

2007p-000638


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

September 2017