Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy

Summary

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.

Conditions

• HIV Infections
• Pregnancy

Interventions

DRUG

Lopinavir / ritonavir

Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation and maintained for at least 6 weeks after delivery.

DRUG

Lopinavir/ritonavir

Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation, increase the lopinavir/r dosage (200/50 mg, 3 tablets every 12 hours) in the third trimester (from 25 weeks on), and return to standard dose(200/50 mg, 2 tablets every 12 hours)for at least 6 weeks after delivery.

Sponsors & Collaborators

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Oswaldo Cruz Foundation

  lead OTHER

Principal Investigators

• Marilia S Oliveira, MD · IPEC - Oswaldo Cruz Foundation

• Beatriz J Grinsztejn, MD · IPEC - Oswaldo Cruz Foundation

• Eduardo W Barroso, MD · IPEC - Oswaldo Cruz Foundation

• Valdilea G Veloso-Santos, MD · IPEC - Oswaldo Cruz Foundation

• José Henrique S Pilotto, MD · Hospital Geral de Nova Iguaçu (HGNI)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2012-07-31

Completion

2012-07-31

Countries

• Brazil

Study Locations