The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet
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ClinicalTrials.gov Identifier: NCT00766818 |
Recruitment Status
:
Completed
First Posted
: October 6, 2008
Last Update Posted
: May 13, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy HIV | Drug: Kaletra | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Kaletra
|
Drug: Kaletra
Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID
Other Names:
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- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766818
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Angela DM Kashuba, PharmD | University of North Carolina | |
Principal Investigator: | Kristine B Patterson, MD | University of North Carolina |
Responsible Party: | Angela Kashuba, PharmD, University of North Carolina |
ClinicalTrials.gov Identifier: | NCT00766818 History of Changes |
Other Study ID Numbers: |
IRB #06-0653 |
First Posted: | October 6, 2008 Key Record Dates |
Last Update Posted: | May 13, 2011 |
Last Verified: | May 2011 |
Additional relevant MeSH terms:
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |