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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Hiv

Treatments

Other: a swab of mucous membrane

Study type

Interventional

Funder types

Other

Identifiers

NCT03640923
2018-23

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

experimental group
Experimental group
Description:
Child with a proven infection of the mother or both biological parents known to HIV antenatal a swab of mucous membrane will be withdrawed
Treatment:
Other: a swab of mucous membrane

Trial contacts and locations

0

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Central trial contact

AURELIE MORAND, MD

Data sourced from clinicaltrials.gov

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