A prospective, multi-centric, open-label, single arm study to evaluate the safety and efficacy of 4mg of ZYH1 in hypertriglyceridemia in HIV associated lipodystrophy - NA

Cadila Healthcare Limited0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Age 18- 65 years
•Subjects should have confirmed diagnosis of HIV 1 and on highly active antiretroviral therapy (HAART) for at last 18 months.
•On stable ART regimen for at least 8 weeks prior to inclusion in the study and ART regimen not expected to change in next 3 months.
•Subjects clinically diagnosed as HIV Lipodystrophy (at least 1 moderate or severe Lipodystrophy feature identified by doctor and patient, except isolated abdominal obesity)
•Triglycerides between 200 - 500 mg%
•Subject has given informed consent for participation in this trial
•Subjects whose CD4 count is > 50/mm3

•Subjects on insulin and/or glitazone / glitazar therapy
•Pregnancy and lactation
•Subjects with history of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2.5 times of upper limits of normal or Bilirubin more than 2 times UNL
•Renal dysfunction (serum creatinine > 2 mg%)
•Subjects with history of gall stone.
•Subjects with history of Cardiac failure.
•Subjects with history of myopathies or evidence of active muscle diseases or CPK ≥10 times UNL
•Subject with history of alcohol and/or drug abuse
•History of allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
•History of active Opportunistic infection in last three months.
•History of malignancy or active neoplasm.
•Any active hormonal disease and/or hormonal treatment that may affect the outcomes of interest such as clinically overt hypo/hyperthyroidism, hypogonadism, hypercortisolism, or treatment with steroids or growth hormone.
•Hemoglobin below 9 g/dl or Total leukocyte count below 1000/mm3 or Platelet count below 50,000/mm3
•Participation in any other clinical trial in past 3 months

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