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Body Composition and Adipose Tissue in HIV

Primary Purpose

HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tesamorelin
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Lipodystrophy Syndrome focused on measuring HIV Lipodystrophy, Tesamorelin, Body Composition, Visceral Adiposity

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuroendocrine Unit and Pituitary Center, Columbia UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tesamorelin

Arm 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.

Outcomes

Primary Outcome Measures

Change in Hepatic Lipid Content
Hepatic lipid content measured by abdominal magnetic resonance imaging (MRI)

Secondary Outcome Measures

Change in Visceral Adipose Tissue (VAT) mass
Visceral adipose tissue mass measured by abdominal MRI
Change in Relative gene expression of CD68 gene
Relative gene expression of CD68 gene in adipose tissue
Change in Relative gene expression on TNF-alpha gene
Relative gene expression of tumor necrosis factor (TNF)-alpha gene in adipose tissue
Change in Resting Energy Expenditure (REE)
Resting metabolic rate measured by indirect calorimetry

Full Information

First Posted
July 20, 2017
Last Updated
October 24, 2022
Sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03226821
Brief Title
Body Composition and Adipose Tissue in HIV
Official Title
Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition
Keywords
HIV Lipodystrophy, Tesamorelin, Body Composition, Visceral Adiposity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tesamorelin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tesamorelin
Other Intervention Name(s)
Egrifta
Intervention Description
Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily
Primary Outcome Measure Information:
Title
Change in Hepatic Lipid Content
Description
Hepatic lipid content measured by abdominal magnetic resonance imaging (MRI)
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in Visceral Adipose Tissue (VAT) mass
Description
Visceral adipose tissue mass measured by abdominal MRI
Time Frame
Baseline and 12 months
Title
Change in Relative gene expression of CD68 gene
Description
Relative gene expression of CD68 gene in adipose tissue
Time Frame
Baseline and 12 months
Title
Change in Relative gene expression on TNF-alpha gene
Description
Relative gene expression of tumor necrosis factor (TNF)-alpha gene in adipose tissue
Time Frame
Baseline and 12 months
Title
Change in Resting Energy Expenditure (REE)
Description
Resting metabolic rate measured by indirect calorimetry
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Reyes-Vidal, MD
Phone
212-305-4921
Email
csr52@columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Freda, MD
Phone
212-305-2254
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela U. Freda, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuroendocrine Unit and Pituitary Center, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela U. Freda, MD
Phone
212-305-2254
First Name & Middle Initial & Last Name & Degree
Carlos M. Reyes-Vidal, MD
Phone
212-305-4921
Email
csr52@cumc.columbia.edu

12. IPD Sharing Statement

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Body Composition and Adipose Tissue in HIV

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