Clinical trial NCT03640923: Germinal Transmission After Endogenization of HIV Sequences Without a Competent Virus for Replication and a Potential Protective Role
Official title: Study of the Germinal Transmission After Endogenization of HIV Sequences Without a Competent Virus for Replication and a Potential Protective Role
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hiv
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 200
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Absence of parents consents

Primary outcomes:
measure: Number of child with HIV genome sequences
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Des Hopitaux de Marseille
state: Paca
Study officials:
affiliation: APHM
name: EMILIE GARRIDO PRADALIE
role: STUDY_DIRECTOR
References: