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

NCT03640923 | Unknown

• 1 other identifier: 2018-23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• Number of child with HIV genome sequences

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

  1 day

Study Arms (1)

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

Other: a swab of mucous membrane

Interventions

a swab of mucous membrane OTHER

a swab of mucous membrane in oredre to analyse the genome

experimental group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Absence of parents consents

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

AURELIE MORAND, MD

CONTACT

+33491381878; AURELIE.MORAND@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: December 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

FR (1)