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The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766818
First Posted: October 6, 2008
Last Update Posted: May 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of North Carolina, Chapel Hill
  Purpose
In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting ~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).

Condition Intervention Phase
Pregnancy HIV Drug: Kaletra Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet: A Longitudinal Investigation in the Second and Third Trimesters Including Empiric Dosage Adjustment

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • To compare the C12h and AUC0-12h of protein bound and unbound blood plasma lopinavir (LPV) using standard doses during the second and third trimesters of pregnancy. [ Time Frame: 20-24 weeks, 30weeks, 32 weeks gestation and 8 weeks postpartum ]
  • To compare the C12h and AUC0-12h of protein bound and unbound blood plasma LPV between standard doses (400mg/100mg BID) and increased doses (500/125mg BID) of Kaletra® during the third trimester of pregnancy. [ Time Frame: 20-24weeks, 30 weeks, 32 weeks gestation, 8weeks postpartum ]

Secondary Outcome Measures:
  • To compare the C12h and AUC0-12h of protein bound and unbound blood plasma ritonavir (RTV) using standard doses during the second and third trimesters of pregnancy. [ Time Frame: 20-24weeks, 30weeks, 32weeks gestation, 8 weeks postpartum ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Kaletra
Drug: Kaletra
Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID
Other Names:
  • lopinavir
  • ritonovir

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive
  • Pregnant (<22 weeks)
  • Currently taking or planning to start Kaletra
  • ≥18 years of age

Exclusion Criteria:

  • Active opportunistic or serious bacterial infection at the time of entry
  • Past or present obstetrical complications (including, but not limited to: placentia previa, eclampsia, confirmed birth defects, multiple gestation pregnancies)
  • Unable to maintain medication adherence, defined as ≥ 80% of doses taken between visits
  • Currently receiving or expected to receive other protease inhibitors in conjunction with Kaletra®
  • HIV genotype showing accumulation of protease inhibitor mutations expected to result in virologic failure on Kaletra® OR documented virologic failure on Kaletra®-containing regimen attributable to the Kaletra® component
  • Chronic hepatitis B and/or C virus infection
  • Cushing's Syndrome
  • Untreated hypothyroidism or hyperthyroidism
  • Serum Creatinine > 1.5 mg/dL
  • Amylase 1.5 times ULN and/or abnormal lipase
  • Direct or total bilirubin levels > Grade 1
  • ALT/AST > Grade 2 (based on the NIH Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events
  • Bicarbonate > Grade 2 (DAIDS)
  • Hematology > Grade 2 (DAIDS), except for anemia: exclude only women with Hb< 9 g/dL and/or HCT , 27.3% (< 8.5 mg/dL and/or HCT , 25.6% if currently on ZDV) at screening; all subjects with anemia who enroll in the study must be receiving or start hematinics, including iron and folate supplements, immediately upon enrollment and continue until anemia resolves or end of pregnancy. The hematinic supplements may be discontinued at the discretion of the investigator if they consider continuation would not be in the best interest of the subject.
  • Receiving the following drugs: astemizole, terfenadine, rifampin, cisapride, ergot derivatives, simvastatin, lovastatin, St. John's wort, pimozide, midazolam, triazolam, carbamezapine, phenobarbital, phenytoin, or dexamethasone
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766818


Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Angela DM Kashuba, PharmD University of North Carolina
Principal Investigator: Kristine B Patterson, MD University of North Carolina
  More Information

Responsible Party: Angela Kashuba, PharmD, University of North Carolina
ClinicalTrials.gov Identifier: NCT00766818     History of Changes
Other Study ID Numbers: IRB #06-0653
First Submitted: October 3, 2008
First Posted: October 6, 2008
Last Update Posted: May 13, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors