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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Triglycerides
研究概览
简要总结
This is 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. Subjects should be clinically diagnosed as HIV Lipodystrophy with confirmed diagnosis of HIV 1 and on highly active antiretroviral therapy (HAART) for at last 18 months with Triglyceride level ranging between 200 to 500 mg% .before getting enrolled in the trial. The required sample size for this study to achieve 80% power at the 5% level of significance is a total of 50 subjects. The primary efficacy variable is the Reduction in Triglyceride (TG) at Week 6 and 12 of the treatment period compared with baseline. The change from baseline will be determined as the difference between the means for the treatment period (Week 6 and12) and the baseline. For the efficacy endpoints, treatment effect will be evaluated using an analysis of variance (ANOVA) model. Treatment effects will be estimated using the least-square means and 95% confidence intervals (CIs) from the ANOVA model. Statistical significance will be defined as a two-sided p-value <0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 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
- •500 mg% Subject has given informed consent for participation in this trial Subjects whose CD4 count is > 50/mm3.
排除标准
- •Subjects on insulin and/or glitazone / glitazar therapyPregnancy and lactationSubjects 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 UNLRenal 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 UNLSubject with history of alcohol and/or drug abuseHistory 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/mm3Participation in any other clinical trial in past 3 months.
结局指标
主要结局
Triglycerides
时间窗: At 6 weeks and 12 weeks
次要结局
- Low density lipoprotein (LDL),(Very low density lipoprotein (VLDL) High density lipoprotein (HDL))