The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766818
• Other study ID #: IRB #06-0653
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2008
• Last updated: May 11, 2011
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: May 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Pregnancy

Intervention

Drug:
• Kaletra
Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		20-24 weeks, 30weeks, 32 weeks gestation and 8 weeks postpartum	No
Primary	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.		20-24weeks, 30 weeks, 32 weeks gestation, 8weeks postpartum	No
Secondary	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.		20-24weeks, 30weeks, 32weeks gestation, 8 weeks postpartum	No