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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hiv
• Intervention / Treatment: Other: a swab of mucous membrane

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13354
      • Assistance Publique Des Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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; a swab of mucous membrane in oredre to analyse the genome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of child with HIV genome sequences	Presence or absence of HIV genome sequences within the child's epithelial cells.	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2018-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No