N/A
N=54
Effects of Growth Hormone Releasing Hormone in HIV
HIV · HIV Lipodystrophy
Bottom Line
View on ClinicalTrials.gov: NCT01263717 ↗Enrolled (actual)
54
Serious AEs
12.0%
Results posted
Oct 2014
Primary outcome: Primary: Liver Fat — -2.0; 0.9 Change in hepatic lipid-to-water %
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tesamorelin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Fat |
-2.0; 0.9 | — |
| PRIMARY Visceral Adipose Tissue |
-34; 8 | — |
| SECONDARY Intramyocellular Lipid |
-1.7; -0.2 | — |
| SECONDARY Endogenous Growth Hormone Secretion |
0.35; -0.01 | — |
| SECONDARY Insulin Sensitivity |
0.4; 0.7 | — |
| SECONDARY HbA1c |
0.20; 0.02 | — |
| SECONDARY Insulin Like Growth Factor 1 (IGF-I) |
79; 7 | — |
| SECONDARY Lipid Panel |
-25; -10 | — |
| SECONDARY Carotid Intimal Medial Thickness (cIMT) |
-0.03; -0.00 | — |
| SECONDARY Glucose Tolerance |
-1; -8 | — |
| SECONDARY Adiponectin |
0; 0 | — |
| SECONDARY Hemostatic Markers |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women age 18-65
- Previously diagnosed HIV infection
- Stable antiviral regimen for at least 12 weeks prior to enrollment
- 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
- 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
- For female subjects 40yo or older, negative mammogram within one year of baseline
Exclusion Criteria
- 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 126 mg/dL, SGOT > 2.5 times ULN, HgB 1.4 mg/dL, CD4 count 5 ng/mL
- Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
- For women, positive urine hCG
- Oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study.
- Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip.
Data sourced from ClinicalTrials.gov (NCT01263717). 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.