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

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ClinicalTrials.gov Identifier: NCT00605098
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : October 28, 2013
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Marilia Santini de Oliveira, Oswaldo Cruz Foundation

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE January 30, 2008
Last Update Posted Date October 28, 2013
Study Start Date  ICMJE February 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
Pharmacokinetic parameters of the tablet formulation of lopinavir/r [ Time Frame: Second and third pregnancy trimester and 6 weeks after delivery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood [ Time Frame: Delivery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy
Official Title  ICMJE Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy in HIV-infected Women
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Pregnancy
Intervention  ICMJE
  • 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 Name: Kaletra
  • 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 Name: Kaletra
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Lopinavir / ritonavir
  • Experimental: 2
    Intervention: Drug: Lopinavir/ritonavir
Publications * Santini-Oliveira M, Estrela Rde C, Veloso VG, Cattani VB, Yanavich C, Velasque L, Torres TS, Marins LM, Pilotto JH, João EC, Gonçalves JC, Grinsztejn B. Randomized clinical trial comparing the pharmacokinetics of standard- and increased-dosage lopinavir-ritonavir coformulation tablets in HIV-positive pregnant women. Antimicrob Agents Chemother. 2014 May;58(5):2884-93. doi: 10.1128/AAC.02599-13. Epub 2014 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00605098
Other Study ID Numbers  ICMJE PK-LPV 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marilia Santini de Oliveira, Oswaldo Cruz Foundation
Study Sponsor  ICMJE Oswaldo Cruz Foundation
Collaborators  ICMJE Ministry of Health, Brazil
Investigators  ICMJE
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)
PRS Account Oswaldo Cruz Foundation
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP