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Body Composition and Adipose Tissue in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03226821
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : April 11, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University

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.

Condition or disease Intervention/treatment Phase
HIV Lipodystrophy Syndrome Growth Hormone Deficiency Body Composition Drug: Tesamorelin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: Tesamorelin
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.
Drug: Tesamorelin
Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily
Other Name: Egrifta

Primary Outcome Measures :
  1. Change in Hepatic Lipid Content [ Time Frame: Baseline and 12 months ]
    Hepatic lipid content measured by abdominal magnetic resonance imaging (MRI)

Secondary Outcome Measures :
  1. Change in Visceral Adipose Tissue (VAT) mass [ Time Frame: Baseline and 12 months ]
    Visceral adipose tissue mass measured by abdominal MRI

  2. Change in Relative gene expression of CD68 gene [ Time Frame: Baseline and 12 months ]
    Relative gene expression of CD68 gene in adipose tissue

  3. 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

  4. Change in Resting Energy Expenditure (REE) [ Time Frame: Baseline and 12 months ]
    Resting metabolic rate measured by indirect calorimetry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03226821

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Contact: Carlos Reyes-Vidal, MD 212-305-4921
Contact: Pamela Freda, MD 212-305-2254

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United States, New York
Neuroendocrine Unit and Pituitary Center, Columbia University Recruiting
New York, New York, United States, 10032
Contact: Pamela U. Freda, MD    212-305-2254      
Contact: Carlos M. Reyes-Vidal, MD    212-305-4921   
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Pamela U. Freda, MD Columbia University
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Responsible Party: Pamela U. Freda, Professor of Medicine, Columbia University Identifier: NCT03226821    
Other Study ID Numbers: AAAR2634
R01DK110771 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pamela U. Freda, Columbia University:
HIV Lipodystrophy
Body Composition
Visceral Adiposity
Additional relevant MeSH terms:
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HIV-Associated Lipodystrophy Syndrome
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Growth Substances
Physiological Effects of Drugs