跳至主要内容
临床试验/NCT02102048
NCT02102048Unknown不适用

ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Boosted or Unboosted Atazanavir

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value

研究概览

简要总结

The association between HIV infection , insulin resistance and diabetes mellitus is the topic of many studies that have attempted to analyze the problem from different points of view. In fact, the risk of insulin resistance in HIV-positive patients on antiretroviral therapy seems to depend not only on the same factors that determine its incidence in the general population , but also on the effects of antiretroviral therapy on glucose metabolism. To confirm this observation, studies that have evaluated the incidence of diabetes in patients with HIV infection on antiretroviral therapy have shown that the incidence of diabetes in infected individuals is significantly higher than that observed in the uninfected population. Moreover others preliminar stadies observed that protease inhibitors may induce hyperglycemia and diabetes mellitus. Anyway at this moment no large data are available that indicate the utility to modify the antiretroviral therapy in HIV positive patients with a damage of glucose metabolism.

ATAGLU is a cohort composed by HIV positive patients in effective and stable combined antiretroviral therapy (cART) with undetectable viral load. All patients studied had carried out a therapy with Lopinavir/Ritonavir (LPV/r) + optimal backbone therapy (OBT) and then in part switch to Atazanavir (ATV) + OBT or Atazanavir/ritonavir (ATV/r) + OBT , in part continue with LPV/r + OBT .

The objective was to characterize the changes of carbohydrate profile of a cohort of patients who made a switch from a regimen with LPV/r to boosted or unboosted ATV.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV postive patients
  • Patients on stable and effective antiretroviral therapy with a Protease Inhibitor

排除标准

  • use of Atazanavir before the enrolment
  • pregnancy

研究组 & 干预措施

Atazanavir

Active Comparator

patients that switch cART to boosted or unboosted ATV

干预措施: Atazanavir (Drug)

结局指标

主要结局

Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value

时间窗: 1 year

difference between Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV

次要结局

  • insulinemia(1 year)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giancarlo Ceccarelli

MD, PhD, MSc

University of Roma La Sapienza

研究点 (1)

Loading locations...

相似试验

ATAGLU: Study of Glucose Metabolism in HIV Positive... | 临床试验