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CompletedNCT00605098Updated Oct 28, 2013

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

A Phase 4 interventional study of Lopinavir / ritonavir and Lopinavir/ritonavir in HIV Infections and Pregnancy, sponsored by Oswaldo Cruz Foundation. Completed at 3 sites in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-28.

Sponsored by Oswaldo Cruz Foundation · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • HIV Infections
  • Pregnancy

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Keywords

  • HIV
  • Pregnancy
  • Vertical disease transmission
  • Pharmacokinetics
  • HIV seronegativity
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 60 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Oswaldo Cruz Foundation is the lead sponsor of 42 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    1

    Drug: Lopinavir / ritonavir

  • Experimental
    2

    Drug: Lopinavir/ritonavir

Interventions

  • DrugLopinavir / 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.

    Also known as: Kaletra

  • DrugLopinavir/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.

    Also known as: Kaletra

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameters of the tablet formulation of lopinavir/r

    Time frame: Second and third pregnancy trimester and 6 weeks after delivery

Secondary outcomes

  1. Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood

    Time frame: Delivery

07

Study locations

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

Publications

  • Santini-Oliveira M, Estrela Rde C, Veloso VG, Cattani VB, Yanavich C, Velasque L, Torres TS, Marins LM, Pilotto JH, Joao EC, Goncalves 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. PubMed 24614377 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00605098
Lead sponsor
Oswaldo Cruz Foundation
Collaborators
Ministry of Health, Brazil
Responsible party
Marilia Santini de Oliveira (Medical doctor, Oswaldo Cruz Foundation) — Principal investigator
First posted
Jan 30, 2008
Start date
Feb 2008
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Oct 28, 2013

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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