Brief Title
Body Composition and Adipose Tissue in HIV
Official Title
Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy
Brief 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.
Detailed 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change in Hepatic Lipid Content
Secondary Outcome
Change in Visceral Adipose Tissue (VAT) mass
Condition
HIV Lipodystrophy Syndrome
Intervention
Tesamorelin
Study Arms / Comparison Groups
Tesamorelin
Description: Subjects will be treated with tesamorelin 2 mg by subcutaneous injection daily. Enrolled subjects will have 6 visits - a baseline visit before starting tesamorelin, a visit at 1 month, 3 months, 6 months, 9 months and at 1 year of tesamorelin (GHRH analogue) therapy. Blood sampling for safety labs and clinical examinations will be performed at each visit.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
February 7, 2018
Completion Date
April 30, 2022
Primary Completion Date
April 30, 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - 68 Years
Accepts Healthy Volunteers
No
Contacts
Pamela U. Freda, MD, 212-305-4921, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03226821
Organization ID
AAAR2634
Secondary IDs
R01DK110771
Responsible Party
Principal Investigator
Study Sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor
Pamela U. Freda, MD, Principal Investigator, Columbia University
Verification Date
July 2021