CTRI/2014/08/004885已完成3 期
A prospective, multi-centre, double-blind, randomized, study to evaluate the safety and efficacy of Saroglitazar 4mg versus Placebo in the treatment of HIV associated lipodystrophy. - PRESS IX
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age 18- 65 years.
- •Subjects should have confirmed diagnosis of HIV 1 and on highly active antiretroviral therapy (HAART) for at least 18 months.
- •On stable ART regimen for at least 8 weeks prior to inclusion in the study and ART regimen not expected to change during the study.
- •Subjects with waist circumference >90cm for men and >80cm for women and waist to hip ratio of >0.9 in men and >0.8 in women will be included [3].
- •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 ââ?¬â?? 500 mg%
- •CD4 cell counts >100 cells/mm3
- •Viral load <10,000 copies/ml.
- •Subject has given informed consent for participation in this trial
排除标准
- •Subjects on insulin, or other insulin sensitizer therapy (Thiazolidinediones like Pioglitazone)
- •Subjects with Type I Diabetes.
- •Subjects on lipid lowering drugs (e.g. Fibrates, Statins and Resins) in the previous 3 months.
- •Pregnancy and lactation
- •Positive pregnancy test.
- •Women on Oral Contraceptives or Hormone replacement therapy.
- •Subjects with history of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ââ?°Â¥ 2.5 times of upper limits of normal or Bilirubin more than 2 times UNL.
- •Previous diagnosis of cirrhosis.
- •Previous or current history of bladder disease and/or hematuria.
- •Patients positive for Hepatitis C antigen.
- •Renal dysfunction (serum creatinine 2 mg %)
- •Subjects with history of gall stone.
- •Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV).
- •New or worsening symptoms of coronary heart disease within the past three months or has any of the following within the past 6 months: ACS, worsening CHF, coronary artery intervention, stroke or Transient Ischemic Attack
- •Subjects with history of myopathies or evidence of active muscle diseases
- •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
- •Participation in any other clinical trial in past 3 months
- •Any other condition that in the opinion of the investigator places the patient at risk by enrolling in the study
研究者
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