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临床试验/NCT03640923
NCT03640923Unknown不适用

Study of the Germinal Transmission After Endogenization of HIV Sequences Without a Competent Virus for Replication and a Potential Protective Role

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Number of child with HIV genome sequences

研究概览

简要总结

It is necessary to better understand the transmission of human immunodeficiency virus (HIV) genome sequences by gametes without replication-competent virus transmission. In fact, HIV endogenization could be protective. Some studies are supporting this hypothesis, one shew the presence of HIV genome sequences in spermatozoa, and others show that HIV-positive "Elite controllers" patients have HIV genome sequences without a replication competent virus. One study found HIV genome sequences without a replication-competent virus in the cells of an HIV-negative child whose mother is a non-sick HIV-positive. We will conduct a prospective descriptive and analytical study over a period of 2 years, from September 2018 to November 2020. We will explore by FISH method in the IHU Méditerranée-Infection laboratory, Marseille, the presence or absence of HIV genome sequences without a replication-competent virus in epithelial cells of children with parents are infected by HIV. Children included must be under 12 months of age, followed at Robert Debré Hospital, Paris or Timone Enfant Hospital, Marseille because of a parental HIV infection. They must have the recommended blood tests to assess their HIV status and the parents consent should be written. Subsequent progression to HIV infection or not will be followed and a statistical study will be conducted to establish a link between the presence of endogenized HIV genome sequences in epithelial cells and the developpement or not of HIV infection.

详细描述

It is necessary to better understand the transmission of human immunodeficiency virus (HIV) genome sequences by gametes without replication-competent virus transmission. In fact, HIV endogenization could be protective. Some studies are supporting this hypothesis, one shew the presence of HIV genome sequences in spermatozoa, and others show that HIV-positive "Elite controllers" patients have HIV genome sequences without a replication competent virus. One study found HIV genome sequences without a replication-competent virus in the cells of an HIV-negative child whose mother is a non-sick HIV-positive. We will conduct a prospective descriptive and analytical study over a period of 2 years, from September 2018 to November 2020. We will explore by FISH method in the IHU Méditerranée-Infection laboratory, Marseille, the presence or absence of HIV genome sequences without a replication-competent virus in epithelial cells (non-hematogenous) of children with parents are infected by HIV. Children included must be under 12 months of age, followed at Robert Debré Hospital, Paris or Timone Enfant Hospital, Marseille because of a parental HIV infection. They must have the recommended blood tests to assess their HIV status and the parents consent should be written. Subsequent progression to HIV infection or not will be followed and a statistical study will be conducted to establish a link between the presence of endogenized HIV genome sequences in epithelial cells and the developpement or not of HIV infection.

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
— 至 12 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children included must be under 12 months of age
  • •Followed at Robert Debré Hospital, Paris or Timone Enfant Hospital, Marseille
  • •Parental HIV infection
  • •They must have the recommended blood tests to assess their HIV status
  • •Parents consent should be written

排除标准

  • •Absence of parents consents

研究组 & 干预措施

experimental group

Experimental

Child with a proven infection of the mother or both biological parents known to HIV antenatal a swab of mucous membrane will be withdrawed

干预措施: a swab of mucous membrane (Other)

结局指标

主要结局

Number of child with HIV genome sequences

时间窗: 1 day

Presence or absence of HIV genome sequences within the child's epithelial cells.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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