N/A
N=56
Physiologic Growth Hormone Effects in HIV Lipodystrophy
AIDS · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00100698 ↗Enrolled (actual)
56
Serious AEs
9.1%
Results posted
Jul 2010
Primary outcome: Primary: Change in Visceral Adipose Tissue Area From Baseline to 18 Months — -22; -4 centimeters squared — p=0.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- recombinant human growth hormone (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visceral Adipose Tissue Area From Baseline to 18 Months |
-22; -4 | 0.049 sig |
| SECONDARY Change in Insulin-like Growth Factor-I From Baseline to 18 Months |
109; -25 | — |
| SECONDARY Change in Trunk Fat |
-0.5; 0.2 | — |
| SECONDARY Change in Fasting Glucose |
6; 5 | — |
| SECONDARY Change in Trunk to Extremity Ratio |
-0.4; 0 | — |
| SECONDARY Change in Triglycerides |
-7; 0 | — |
| SECONDARY Change in Subcutaneous Adipose Tissue |
4; 4 | — |
| SECONDARY Change in CD4 Cells |
-19; 15 | — |
| SECONDARY Change in Logarithm HIV Viral Load |
0; 0 | — |
| SECONDARY Change in Lean Body Mass |
0.8; -0.5 | — |
| SECONDARY Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months |
-4; -4 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-3; 4 | — |
| SECONDARY Change in Adiponectin |
1.0; 0.5 | — |
| SECONDARY Change in Carotid Intima Media Thickness (IMT) |
0.003; -0.003 | — |
| SECONDARY Change in Body Mass Index |
0.2; 0.1 | — |
| SECONDARY Change in Extremity Fat |
0.3; 0.3 | — |
| SECONDARY Change in 2-hour Glucose |
16; -4 | — |
| SECONDARY Change in Systolic Blood Pressure |
-5; 1 | — |
Summary
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00100698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.