Effects of Growth Hormone Releasing Hormone in HIV

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01263717
• Date of registration: 16/12/2010
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Effects of Growth Hormone Releasing Hormone in HIV
• Scientific title: Effects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV Lipodystrophy
• Date of first enrolment: December 2010
• Target sample size: 54
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01263717
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Steven Grinspoon, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Lipodystrophy

HIV

Intervention(s)

Drug: tesamorelin

Drug: placebo

Primary Outcome(s)

Liver Fat [Time Frame: 6 months]

Visceral Adipose Tissue [Time Frame: 6 months]

Secondary Outcome(s)

Endogenous Growth Hormone Secretion [Time Frame: 6 months]

Hemostatic Markers [Time Frame: 6 months]

Carotid Intimal Medial Thickness (cIMT) [Time Frame: 6 months]

Insulin Like Growth Factor 1 (IGF-I) [Time Frame: 6 months]

Intramyocellular Lipid [Time Frame: 6 months]

Adiponectin [Time Frame: 6 months]

Insulin Sensitivity [Time Frame: 6 months]

Glucose Tolerance [Time Frame: 6 months]

Lipid Panel [Time Frame: 6 months]

HbA1c [Time Frame: 6 months]

Secondary ID(s)

2007p-000638

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/10/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01263717