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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

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:
  • Kaletra
  • lopinavir
  • ritonovir

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Angela Kashuba, PharmD, University of North Carolina
ClinicalTrials.gov Identifier: NCT00766818     History of Changes
Other Study ID Numbers: IRB #06-0653
Study First Received: October 3, 2008
Last Updated: May 11, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Lopinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014