Body Composition and Adipose Tissue in HIV

Body Composition Clinical Trial

Official title:

Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226821
• Other study ID #: AAAR2634
• Secondary ID: R01DK110771
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Body Composition
• Growth Hormone Deficiency
• HIV Lipodystrophy Syndrome
• HIV-Associated Lipodystrophy Syndrome
• Lipodystrophy

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