DRUG
Tesamorelin
Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily
Status
Terminated
Phase
Phase 4
Enrollment
6
Locations
1
Results
Posted
Publications
0
Study summary
In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.
HIV lipodystrophy is increasingly recognized as a common and clinically significant long-term sequelae of HIV treatment. In the HIV lipodystrophy lipohypertrophy phenotype, visceral adipose tissue (VAT) is increased and this is associated with reduced growth hormone (GH) secretion. Mounting evidence also links this phenotype with dyslipidemia, insulin resistance, subclinical atherosclerosis and cardiovascular (CV) disease in patients with HIV disease. The etiology of HIV lipodystrophy (HIVLD) with central adiposity is unclear, but this phenotype is increasingly common with newer, less lipotoxic combination anti-retroviral therapy (cART) use. VAT and hepatic lipid accumulation, are important health concerns for HIVLD patients. This body composition pattern may contribute to the increased cardiovascular risk that has been demonstrated in patients with HIV lipodystrophy. Patients with HIVLD and central adiposity have been shown to have reduced GH secretion. Thus, a medication has been developed to augment GH secretion. This medication is tesamorelin. GH supplementation in other clinical settings has been shown to reduce visceral adiposity and may reduce hepatic lipid content.
Interventions
DRUG
Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily
Timeline
First posted
Jul 24, 2017
Study start
Feb 7, 2018
Primary completion
Apr 30, 2025
Study completion
Apr 30, 2025
Results posted
May 19, 2026
Registry updated
May 19, 2026
Outcomes
Hepatic Lipid Content
Time frame · Baseline
Hepatic lipid content (percent) will be measured by abdominal magnetic resonance imaging (MRI).
Visceral Adipose Tissue (VAT) Mass
Time frame · Baseline
Visceral adipose tissue mass (kilograms) will be measured by abdominal MRI.
Change in Relative Gene Expression of CD68 Gene
Time frame · Baseline and 12 months
Relative gene expression of CD68 gene in adipose tissue
Change in Relative Gene Expression on TNF-alpha Gene
Time frame · Baseline and 12 months
Relative gene expression of tumor necrosis factor (TNF)-alpha gene in adipose tissue
Change in Resting Energy Expenditure (REE)
Time frame · Baseline and 12 months
Resting metabolic rate measured by indirect calorimetry
Eligibility
Inclusion Criteria: * HIV-infected subjects with HIV lipodystrophy (HIVLD) * Abdominal fat accumulation defined as: Waist Circumference (WC) 102 cm for men, 88 cm for women, except in subjects of East/South Asian ethnicity in whom this will be defined by WC 90 cm for men and 80 cm for women. * Weight stable for 8 weeks prior to enrollment, * CD4 count \>100 cells/mm3 * HIV RNA load \<1000 copies/mL * Fasting plasma glucose \<120 mg/dL * Stable combination anti-retroviral therapy (cART) of any regimen for ≥ 8 weeks prior to study enrollment Exclusion Criteria: * Diabetes mellitus requiring medication * History of any malignancy * Abnormal renal or liver function * Pregnancy or women of childbearing age who are not using an acceptable means of contraception * History disorder of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery * Head irradiation or head trauma or adrenal insufficiency * Systemic glucocorticoid use * Known hypersensitivity to tesamorelin and/or mannitol
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Neuroendocrine Unit and Pituitary Center, Columbia University
New York, New York, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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