Overview

This trial is active, not recruiting.

Conditions hiv-1 infection, pregnancy
Treatment study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy
Phase phase 2
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date July 2014
End date June 2016
Trial size 83 participants
Trial identifier NCT02099474, 2013-004571-12, ANRS 160 RalFE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All women have been prescribed raltegravir before study participation.
study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy raltegravir (Isentress®)
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)

Primary Outcomes

Measure
Comparison of the AUC and raltegravir trough concentration during and after pregnancy
time frame: 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

Measure
Estimation of placental transfer of raltegravir
time frame: Up to 72 hours after delivery
Study of genetic polymorphism which could modify raltegravir concentrations
time frame: Up to 72 hours after delivery
Proportion of women having a viral load < 50 cp/mL at delivery
time frame: Up to 72 hours after delivery
Proportion of maternal-to-child HIV transmission
time frame: Up to 72 hours after delivery
Untimely stop of raltegravir for toxicity or intolerance
time frame: Up to 72 hours after delivery
Clinical and biological anomaly occurring during the third trimester of pregnancy and during the first 6 months of life of the neonate.
time frame: Month 6
Estimation of neonatal elimination of raltegravir
time frame: Up to 72 hours after delivery

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Pregnant woman, between 30 and 37 weeks of amenorrhea - 18 years old and over - Infected by HIV-1 - Receiving a therapeutic combination, stable for at least 15 days before inclusion, with raltegravir at the standard dose (400 mg twice daily) which the doctor plans to maintain till the end of pregnancy and at least one month after delivery - Informed consent signed by mother and investigator (at the latest day of pre-inclusion and before any examination conducted as part of research) - 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 Exclusion Criteria: - 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 ...) - Participating in another research, except the French perinatal survey (ANRS CO1 EPF or ANRS CO11 observatory), including an exclusion period still in progress at the pre-inclusion - Person under guardianship, or deprived of freedom by a judicial or administrative decision

Additional Information

Official title Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy
Principal investigator JADE GHOSN, MD
Description 1. Objectives 1. Principal objective - To study pharmacokinetic properties of raltegravir in pregnant women infected by HIV-1, during the third trimester of pregnancy (between 30 and 37 weeks of amenorrhea) and 1 month after childbirth (between W4 and W6 postpartum), as well as in their neonate. 2. Secondary objectives - Estimate the frequency of women receiving raltegravir and having indetectable viral load at delivery (and those having a strictly indetectable viral load, with no signal under the threshold of the technique used). - Describe the tolerance to raltegravir in pregnant women during the third trimester and in her neonates 2. Methodology - National multicenter pharmacokinetic study conducted among pregnant women infected by HIV-1 and exposed to raltegravir during pregnancy. 3. Statistical method - Method of population pharmacokinetic with 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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).