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临床试验/NCT02457494
NCT02457494已完成不适用

CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV

Corinne Isnard Bagnis1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Qualitative assessment of the cause of the renal stone

研究概览

简要总结

The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

详细描述

This study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

Primary Objective :

  • Finding the cause of renal stone in HIV patients defined as stone composition if stone is available or more probable pathophysiological mechanism
  • Risk profile for stone recurrences estimated on risk indices in HIV1 patients

Secondary Objective(s)

  • Identify prevalence of recurrences and describe co-morbidities associated with stone disease
  • Describe urological management for renal stones in HIV patients
  • Describe the causes of drug induced renal stones

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult male or female HIV1 infected patients willing to participate in the study
  • Having experienced a renal stone episode within the past six months or living with a renal stone
  • Able to understand the protocol
  • Giving oral consent

排除标准

  • CT scan impossible
  • Follow up impossible over 1 year

结局指标

主要结局

Qualitative assessment of the cause of the renal stone

时间窗: at 6 months

Qualitative assessment of the cause of the renal stone based on different biological and clinical parameters (biochemical analysis of urines, cristalluria, low dose renal CT, patient history, family history...)

Risk profile for recurrence of renal stone

时间窗: at 12 months

Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure

次要结局

  • Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease(up to 12 months)
  • Causes of drug induced renal stones(up to 12 months)
  • Number of stone recurrences(at 12 months)
  • Urological management for renal stones in HIV patients(up to 12 months)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Corinne Isnard Bagnis

University Professor and Hospital Practitioner

Association pour le Developpement d'Investigations et de Thérapeutiques en Néphrologie

研究点 (1)

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