Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00766818
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2008-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}, {'id': 'D061466', 'term': 'Lopinavir'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-11', 'studyFirstSubmitDate': '2008-10-03', 'studyFirstSubmitQcDate': '2008-10-03', 'lastUpdatePostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '20-24 weeks, 30weeks, 32 weeks gestation and 8 weeks postpartum'}, {'measure': '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.', 'timeFrame': '20-24weeks, 30 weeks, 32 weeks gestation, 8weeks postpartum'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '20-24weeks, 30weeks, 32weeks gestation, 8 weeks postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy', 'HIV']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV positive\n* Pregnant (\\<22 weeks)\n* Currently taking or planning to start Kaletra\n* ≥18 years of age\n\nExclusion Criteria:\n\n* Active opportunistic or serious bacterial infection at the time of entry\n* Past or present obstetrical complications (including, but not limited to: placentia previa, eclampsia, confirmed birth defects, multiple gestation pregnancies)\n* Unable to maintain medication adherence, defined as ≥ 80% of doses taken between visits\n* Currently receiving or expected to receive other protease inhibitors in conjunction with Kaletra®\n* 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\n* Chronic hepatitis B and/or C virus infection\n* Cushing's Syndrome\n* Untreated hypothyroidism or hyperthyroidism\n* Serum Creatinine \\> 1.5 mg/dL\n* Amylase 1.5 times ULN and/or abnormal lipase\n* Direct or total bilirubin levels \\> Grade 1\n* ALT/AST \\> Grade 2 (based on the NIH Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events\n* Bicarbonate \\> Grade 2 (DAIDS)\n* 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.\n* Receiving the following drugs: astemizole, terfenadine, rifampin, cisapride, ergot derivatives, simvastatin, lovastatin, St. John's wort, pimozide, midazolam, triazolam, carbamezapine, phenobarbital, phenytoin, or dexamethasone"}, 'identificationModule': {'nctId': 'NCT00766818', 'briefTitle': 'The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet: A Longitudinal Investigation in the Second and Third Trimesters Including Empiric Dosage Adjustment', 'orgStudyIdInfo': {'id': 'IRB #06-0653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Kaletra', 'interventionNames': ['Drug: Kaletra']}], 'interventions': [{'name': 'Kaletra', 'type': 'DRUG', 'otherNames': ['lopinavir', 'ritonovir'], 'description': 'Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Angela DM Kashuba, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'Kristine B Patterson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Angela Kashuba, PharmD', 'oldOrganization': 'University of North Carolina'}}}}