HIV Infections Clinical Trial
Official title:
Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy in HIV-infected Women
This is a multicenter, open, prospective and randomized study aimed at evaluating the
pharmacokinetics of the tablet formulation of lopinavir/r administered in combination with
two nucleoside analogs to HIV-infected pregnant women at two different dosages:
- Group 1 (standard dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours, plus two
nucleoside analogs.
- Group 2 (increased dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours until the
end of the second trimester of gestation (24 weeks) and 3 tablets every 12 hours in the
third trimester (from 25 weeks on), plus two nucleoside analogs.
Treatment will be initiated at any time between 14 and 30 weeks of gestation and will be
maintained for at least 6 weeks after delivery.
The objectives are:
- To compare the pharmacokinetic parameters of the standard and increased dosage of the
tablet formulation of lopinavir/r during pregnancy.
- To determine whether the standard and/or increased dosage of the tablet formulation of
lopinavir/r during pregnancy confers the same exposure to the drug as that observed in
the same women after the end of pregnancy and in historic controls.
- To evaluate the transplacental passage of lopinavir/r based on the ratio between the
serum concentration in maternal blood at the time of delivery and in cord blood of the
two drug dosages (standard and increased) administered during pregnancy.
- To evaluate the tolerability of the two lopinavir/r dosages (standard and increased)
during pregnancy.
- To describe the vertical transmission rate of HIV to the children of the pregnant women
included in the study.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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