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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03226821
Other study ID # AAAR2634
Secondary ID R01DK110771
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 7, 2018
Est. completion date April 30, 2025

Study information

Verified date May 2024
Source Columbia University
Contact Carlos Reyes-Vidal, MD
Phone 212-305-4921
Email csr52@columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 68 Years
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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Tesamorelin
Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily

Locations

Country Name City State
United States Neuroendocrine Unit and Pituitary Center, Columbia University New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hepatic Lipid Content Hepatic lipid content measured by abdominal magnetic resonance imaging (MRI) Baseline and 12 months
Secondary Change in Visceral Adipose Tissue (VAT) mass Visceral adipose tissue mass measured by abdominal MRI Baseline and 12 months
Secondary Change in Relative gene expression of CD68 gene Relative gene expression of CD68 gene in adipose tissue Baseline and 12 months
Secondary Change in Relative gene expression on TNF-alpha gene Relative gene expression of tumor necrosis factor (TNF)-alpha gene in adipose tissue Baseline and 12 months
Secondary Change in Resting Energy Expenditure (REE) Resting metabolic rate measured by indirect calorimetry Baseline and 12 months
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