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

October 25, 2013 updated by: Marilia Santini de Oliveira, Oswaldo Cruz Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20221903
        • Hospital dos Servidores do Estado
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21040-900
        • Instituto de Pesquisa Clínica Evandro Chagas
    • Rio de Janeiro
      • Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380
        • Hospital Geral de Nova Iguaçu (HGNI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Capacity to consent and wish to participate in the study, documented by signing the specific informed consent form (ICF) of the study.
  • Age of 18 years or older.
  • Pregnancy documented by urine or blood examination or ultrasound.
  • Gestational age of 14 to 30 weeks calculated by ultrasound, obstetric examination or date of last menstruation, depending on what is considered to be more exact by the medical investigator.
  • HIV infection documented by two serological tests using different methods or analysis of HIV viral load with a positive result.
  • No use of antiretroviral drugs at the time of diagnosis of pregnancy (previous prophylaxis and treatment are allowed).
  • Intention to continue the treatment of the study for at least 6 weeks after delivery.

Exclusion Criteria:

  • History of hypersensitivity to lopinavir or ritonavir.
  • Need for the concomitant use of contraindicated drugs in combination with lopinavir/ritonavir.
  • Any condition that, in the opinion of the medical researchers, impairs the participation in and fulfillment of the procedures of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
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.
Other Names:
  • Kaletra
Active Comparator: 1
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.
Other Names:
  • Kaletra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters of the tablet formulation of lopinavir/r
Time Frame: Second and third pregnancy trimester and 6 weeks after delivery
Second and third pregnancy trimester and 6 weeks after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood
Time Frame: Delivery
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oswaldo Cruz Foundation

Collaborators

Ministry of Health, Brazil

Investigators

  • Principal Investigator: Marilia S Oliveira, MD, IPEC - Oswaldo Cruz Foundation
  • Principal Investigator: Beatriz J Grinsztejn, MD, IPEC - Oswaldo Cruz Foundation
  • Principal Investigator: Eduardo W Barroso, MD, IPEC - Oswaldo Cruz Foundation
  • Principal Investigator: Valdilea G Veloso-Santos, MD, IPEC - Oswaldo Cruz Foundation
  • Principal Investigator: José Henrique S Pilotto, MD, Hospital Geral de Nova Iguaçu (HGNI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PK-LPV 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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