NCT02099474

Brief Summary

The purpose of this study is to assess the evolution of raltegravir concentration in the mother (between the 3rd trimester of pregnancy and one month post-delivery) and her neonate, when this drug is used to prevent mother-to-child HIV-1 transmission as part of a combined antiretroviral regimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

March 19, 2014

Last Update Submit

August 18, 2017

Conditions

HIV-1 InfectionPREGNANCY

Keywords

HIV-1HIV mother to child preventionRaltegravirPharmacokinetic

Outcome Measures

Primary Outcomes (1)

  • Comparison of the AUC and raltegravir trough concentration during and after pregnancy

    5 samples: before the drug intake, 0.5, 3, 8 and 12 hours after the intake at each of the 2 visits (between 30 and 37 weeks of amenorrhea, and 4 to 6 weeks after delivery)

Secondary Outcomes (7)

  • Estimation of placental transfer of raltegravir

    Up to 72 hours after delivery

  • Study of genetic polymorphism which could modify raltegravir concentrations

    Up to 72 hours after delivery

  • Proportion of women having a viral load < 50 cp/mL at delivery

    Up to 72 hours after delivery

  • Proportion of maternal-to-child HIV transmission

    Up to 72 hours after delivery

  • Untimely stop of raltegravir for toxicity or intolerance

    Up to 72 hours after delivery

  • +2 more secondary outcomes

Study Arms (1)

Raltegravir

EXPERIMENTAL

All women have been prescribed raltegravir before study participation.

Other: Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy

Interventions

Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancyOTHER

Introduction of a catheter for performing 5 blood samples in pregnant women infected by HIV-1, before the raltegravir intake, 0.5, 3, 8 and 12 hours after the intake at each of two visits (between 30 and 37 weeks of amenorrhea, and 4 to 6 weeks after delivery)

Also known as: raltegravir (Isentress®)
Raltegravir

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant woman, between 30 and 37 weeks of amenorrhea
  • years old and over
  • Infected by HIV-1
  • Affiliated person or beneficiary of a social security system (medical aid of state or AME is not a social security system)
  • Participant agreeing to be registered in the national file of the people who participate in biomedical researches

You may not qualify if:

  • Infected by HIV-2
  • Under 18 years old
  • Receiving therapeutic association with atazanavir (Reyataz®), fosamprenavir (Telzir®), or efavirenz ( contained in Sustiva® and Atripla®)
  • Currently using medication, drugs or alcohol which can interfere with the research: rifampicine, phénobarbital, phénytoïne, topical gastrointestinal, antiacid and adsorbents
  • Presenting a clinical situation or acute pathology incompatible with the realisation of a pharmacokinetic study.
  • Planned absence which could hinder research participation (travel abroad, moving, imminent transfer ...)
  • Person under guardianship, or deprived of freedom by a judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Hôtel Dieu

Paris, 75004, France

Location

Related Publications (1)

  • Zheng Y, Hirt D, Delmas S, Lui G, Benaboud S, Lechedanec J, Treluyer JM, Chenevier-Gobeaux C, Arezes E, Gelley A, Amri I, Urien S, Bouazza N, Foissac F, Warszawski J, Ghosn J. Effect of Pregnancy on Unbound Raltegravir Concentrations in the ANRS 160 RalFe Trial. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00759-20. doi: 10.1128/AAC.00759-20. Print 2020 Sep 21.

    PMID: 32661003DERIVED

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • JADE GHOSN, MD

    CHU Hôtel Dieu PARIS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 31, 2014

Study Start

June 30, 2014

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

FR(1)