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临床试验/NCT03161444
NCT03161444终止不适用

Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection.

University Hospital Center of Martinique4 个研究点 分布在 2 个国家目标入组 354 人开始时间: 2017年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
354
试验地点
4
主要终点
Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic

研究概览

简要总结

This study will estimate the cumulative incidence of Zika infection at the end of the first epidemic in the French West Indies in a sample of patients followed for HIV infection.

详细描述

Zika virus infection is expanding in all tropical and subtropical areas. The presence of Aedes albopictus in southern France raises concerns about the occurrence of outbreaks of indigenous Zika virus transmission. In this context, knowledge of the cumulative impact of the epidemic that affected the Caribbean in 2016 is an important issue for the management of future epidemics and modeling work. Since the Zika virus has not yet been circulated in the Lesser Antilles, the cumulative incidence rate can be estimated by conducting a general population seroprevalence survey at the end of the epidemic, or more simply within a cohort of patients regularly monitored and whose habitat is distributed throughout the study area. Thus, HIV-infected patients who benefit from regular clinical biological monitoring constitute a population sample perfectly adapted to the study of the emergence of the Zika virus in the French West Indies. The cumulative incidence of infection with the chikungunya virus after the 2014 epidemic has thus been estimated at 58% for Martinique and Guadeloupe using this method.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Adult (> 18 years pold)
  • Followed for HIV infection at the 2 investigators centers (1 located at Martinique and 1 at Guadeloupe)
  • Resident in Martinique /Guadeloupe (French West Indies) betwwen 01JAN2016 and 31DEC2016
  • Affiliate or beneficiary of a social security scheme.
  • Informed consent signed by the patient

排除标准

  • Patient who has stayed in another area at risk of transmission of the Zika virus

结局指标

主要结局

Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic

时间窗: 1 day

Presence or absence of ZIKV-specific IgG antibodies in the serum taken at the end of the Zika epidemic within six months of the official end of the epidemic for each territory of the French west Indies

次要结局

  • Presence or not of Dengue virus specific antibodies before the outbreak of Zika virus infection, sought on the samples taken at the end of the chikungunya epidemic.(1 day on biological sample collected before the outbreak of Zika virus)
  • Existence or not of clinical signs evocating of an episode of disease with Zika virus.(1 day during the study)
  • Evolution of the HIV1 RNA levels before and after the outbreak of Zika virus(6 months before the outbreak of Zika virus ; 12 months of the outbreak of Zika virus; First 6 months after the outbreak of Zika virus)
  • Evolution of the CD4 lymphocyte levels before and after the outbreak of Zika virus(6 months before the outbreak of Zika virus ; 12 months of the outbreak of Zika virus; First 6 months after the outbreak of Zika virus)
  • Presence or not of Chikungunya-specific antibodies before the outbreak of Zika virus infection, sought after sampling at the end of the chikungunya epidemic.(1 day on biological sample collected before the outbreak of Zika virus)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (4)

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