Body Composition and Adipose Tissue in HIV

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Lipodystrophy
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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