Yükleniyor... / Loading...
This study examined the effects of the drug Tesamorelin on body composition and fat tissue in people with HIV-associated lipodystrophy (abnormal fat distribution). It enrolled people with HIV who had abdominal fat accumulation, stable weight, and a steady antiretroviral therapy regimen. It was carried out in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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