Evaluation of Raltegravir During the Third Trimester of Pregnancy

NCT ID: NCT02099474

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-04-30

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.

Detailed 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).

Conditions

HIV-1 Infection; PREGNANCY

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raltegravir

All women have been prescribed raltegravir before study participation.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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)

Interventions

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

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)

Intervention Type: OTHER

Other Intervention Names

raltegravir (Isentress®)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JADE GHOSN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Hôtel Dieu PARIS

Locations

CHU Hôtel Dieu

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32661003 (View on PubMed)

Other Identifiers

2013-004571-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ANRS 160 RalFE

Identifier Type: -

Identifier Source: org_study_id