Evaluation of Raltegravir During the Third Trimester of Pregnancy

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02099474
Study type	Interventional
Source	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact
Status	Completed
Phase	Phase 2
Start date	June 30, 2014
Completion date	April 2017

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Evaluation of Raltegravir During the Third Trimester of Pregnancy — ANRS 160 RalFE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms