Pregnancy, Anti-integrase and Lymphocyte Repertoire of th... | NCT04024150

Studies
Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

NCT04024150

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Mar 9, 2026Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Anti-integrases

Interventions

Blood test

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A00926-51	Other Identifier	ID RCB number

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2019Actual

Primary Completion Date

Jan 14, 2021Actual

Completion Date

Jan 14, 2021Actual

First Submitted Date

Jul 2, 2019

First Submission Date that Met QC Criteria

Jul 16, 2019

First Posted Date

Jul 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2026

Last Update Posted Date

Mar 9, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.

Detailed Description

Antiretroviral treatment during pregnancy is remarkably effective in preventing the transmission of mother-to-child viruses. Molecules of the class of anti-integrases are still little used during pregnancy, but their prescription is increasing given their intrinsic effectiveness and their overall tolerance profile.

The integrase of HIV-1, responsible for the integration of viral DNA in cellular DNA, has a functional similarity with human RAG1 / 2 proteins, responsible for V (D) J recombination. RAG1 / 2 proteins alteration is associated in human clinic with immune disturbances of varied severity.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Newborns exposed		Newborns exposed in-utero to raltegravir	Biological: Blood test
Newborns controls		Newborns exposed to antiretroviral therapy without anti-integrase	Biological: Blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Biological	Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup	Newborns controls Newborns exposed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Newborn immunity	T cells immune repertoire integrity	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No parental opposition after information. "Exposed" group :
Newborn at term exposed to raltegravir (RTG) before 8 weeks of gestation and until the end of pregnancy. Children exposed to elvitegravir (ETG), dolutegravir (DTG) or bictegravir (BTG) may be included but will be analyzed separately.

"Control" group :

- Term neonate exposed to antiretroviral therapy without anti-integrase.

Exclusion Criteria:

Prematurity less than 36 weeks of gestation.
Organ dysfunction.
Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Newborns exposed in utero to an antiretroviral therapy and born in the maternities of Paris AP-HP hospitals: Necker, Pitié-Salpétrière, Bichat, Louis Mourier and Cochin (Port-Royal).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stéphane Blanche, MD-PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator
Jean-Pierre de Villartay	Institut National de la Santé Et de la Recherche Médicale, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AP-HP, Hôpital Louis Mourier		Colombes		92700	France
AP-HP, Hôpital de la Pitié Salpêtrière

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36343360	Result	de Villartay JP, Pannier E, Sibiude J, Frange P, Tubiana R, Blanche S. Brief Report: T-Cell Receptor alpha Repertoire Diversity at Birth After in utero Exposure to HIV Integrase Strand-Transfer Inhibitors. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):260-262. doi: 10.1097/QAI.0000000000003130.

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques