Body Composition and Adipose Tissue in HIV

NCT03226821 | Completed Phase 4 FDA Drug

• 2 other identifiers: AAAR2634R01DK110771
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Lipodystrophy Syndrome; Growth Hormone Deficiency; Body Composition

Keywords

HIV Lipodystrophy; Tesamorelin; Body Composition; Visceral Adiposity

Outcome Measures

Primary Outcomes (1)

• Change in Hepatic Lipid Content

  Hepatic lipid content measured by abdominal magnetic resonance imaging (MRI)

  Baseline and 12 months

Secondary Outcomes (4)

• Change in Visceral Adipose Tissue (VAT) mass

  Baseline and 12 months

• Change in Relative gene expression of CD68 gene

  Baseline and 12 months

• Change in Relative gene expression on TNF-alpha gene

  Baseline and 12 months

• Change in Resting Energy Expenditure (REE)

  Baseline and 12 months

Study Arms (1)

Tesamorelin

EXPERIMENTAL

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

Interventions

Tesamorelin DRUG

Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily

Also known as: Egrifta

Tesamorelin

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Neuroendocrine Unit and Pituitary Center, Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

HIV-Associated Lipodystrophy Syndrome; Dwarfism, Pituitary

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Pamela U. Freda, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: February 7, 2018
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)