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The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00766818
First received: October 3, 2008
Last updated: May 11, 2011
Last verified: May 2011

October 3, 2008
May 11, 2011
January 2007
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00766818 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet
The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet: A Longitudinal Investigation in the Second and Third Trimesters Including Empiric Dosage Adjustment

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy
  • HIV
Drug: Kaletra
Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID
Other Names:
  • Kaletra
  • lopinavir
  • ritonovir
Experimental: 1
Kaletra
Intervention: Drug: Kaletra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00766818
IRB #06-0653
No
Angela Kashuba, PharmD, University of North Carolina
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Angela DM Kashuba, PharmD University of North Carolina
Principal Investigator: Kristine B Patterson, MD University of North Carolina
University of North Carolina, Chapel Hill
May 2011

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