Body Composition and Adipose Tissue in HIV

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Growth Hormone-Releasing Hormone; Tesamorelin

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