PREGNANCY Clinical Trial
Official title:
Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy
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.
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).
;
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