The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet - Full Text View

Sponsors and Collaborators:	The University of North Carolina, Chapel Hill National Institutes of Health (NIH)
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00766818

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 IV

MedlinePlus related topics: AIDS AIDS and Pregnancy

Drug Information available for: Lopinavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by The 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Kaletra	Drug: Kaletra Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766818

Contacts

Contact: Amanda E Jones, PharmD

919-843-8723

amanda_jones@unc.edu

Locations

United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Amanda E Jones, PharmD 919-843-8723 amanda_jones@unc.edu
Principal Investigator: Kristine Patterson, MD
Principal Investigator: Angela DM Kashuba, PharmD

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

National Institutes of Health (NIH)

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:	University of North Carolina ( Angela Kashuba, PharmD and Kris Patterson,MD )
Study ID Numbers:	IRB #06-0653
Study First Received:	October 3, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00766818
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Lopinavir
HIV Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009