Physiologic Growth Hormone Effects in HIV Lipodystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00100698
• Date of registration: 04/01/2005
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Physiologic Growth Hormone Effects in HIV Lipodystrophy
• Scientific title: Physiologic Growth Hormone Effects in HIV Lipodystrophy
• Date of first enrolment: January 2004
• Target sample size: 56
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00100698
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

AIDS

Intervention(s)

Drug: recombinant human growth hormone

Drug: placebo

Primary Outcome(s)

Change in Visceral Adipose Tissue Area From Baseline to 18 Months [Time Frame: 18 months]

Secondary Outcome(s)

Change in Lean Body Mass [Time Frame: 18 months]

Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months [Time Frame: 18 months]

Change in Body Mass Index [Time Frame: 18 months]

Change in Triglycerides [Time Frame: 18 months]

Change in Extremity Fat [Time Frame: 18 months]

Change in Subcutaneous Adipose Tissue [Time Frame: 18 months]

Change in Trunk Fat [Time Frame: 18 months]

Change in 2-hour Glucose [Time Frame: 18 months]

Change in Fasting Glucose [Time Frame: 18 months]

Change in Diastolic Blood Pressure [Time Frame: 18 months]

Change in Insulin-like Growth Factor-I From Baseline to 18 Months [Time Frame: 18 months]

Change in Logarithm HIV Viral Load [Time Frame: 18 months]

Change in Adiponectin [Time Frame: 18 months]

Change in Carotid Intima Media Thickness (IMT) [Time Frame: 18 months]

Change in Trunk to Extremity Ratio [Time Frame: 18 months]

Change in CD4 Cells [Time Frame: 18 months]

Change in Systolic Blood Pressure [Time Frame: 18 months]

Secondary ID(s)

DK63639

R01DK063639

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Results

• Results available: Yes
• Date Posted: 22/07/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00100698