The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

NCT00766818 | Completed Phase 1

• 1 other identifier: IRB #06-0653
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pregnancy; HIV

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Kaletra

Drug: Kaletra

Interventions

Kaletra DRUG

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

Also known as: lopinavir, ritonovir

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

lopinavir-ritonavir drug combination; Lopinavir

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Angela DM Kashuba, PharmD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Kristine B Patterson, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

US (1)