NCT02099474

Evaluation of Raltegravir During the Third Trimester of Pregnancy

Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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)

Timeline

• Start date: 2014-06-30
• Primary completion: 2017-01-01
• Completion: 2017-04-01
• First posted: 2014-03-31
• Last updated: 2017-08-22

Locations

1 site across 1 country: France