Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-04 @ 9:58 PM
Study NCT ID:
NCT00294892
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2006-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study on Nevirapine Resistance in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D019829', 'term': 'Nevirapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-26', 'studyFirstSubmitDate': '2006-02-21', 'studyFirstSubmitQcDate': '2006-02-21', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cord blood will be taken less than 30 minutes after delivery', 'timeFrame': '0 - 30 min after delivery'}, {'measure': 'Blood samples from mother will be taken less than 30 minutes after delivery to measure viral load and CD4 count.', 'timeFrame': '0 - 30 min after delivery'}, {'measure': 'Blood samples will be drawn from mother and child at week 1 (day 6-8), week 2 (day 13-15) and week 3 (day 20-22)', 'timeFrame': 'day 6 - 22 after delivery'}, {'measure': 'From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns.', 'timeFrame': '0 30 min after delivery - week 3 after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'mother to child transmission; MTCT', 'nevirapine resistance', 'pharmacokinetics', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '22134145', 'type': 'DERIVED', 'citation': "Muro EP, Fillekes Q, Kisanga ER, L'homme R, Aitken SC, Mariki G, Van der Ven AJ, Dolmans W, Schuurman R, Walker AS, Gibb DM, Burger DM. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. doi: 10.1097/QAI.0b013e31824234d8."}], 'seeAlsoLinks': [{'url': 'http://journals.lww.com/jaids/Abstract/2012/03010/Intrapartum_Single_Dose_Carbamazepine_Reduces.7.aspx', 'label': 'J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention.'}]}, 'descriptionModule': {'briefSummary': 'Primary\n\n* pharmacokinetics of single dose nevirapine\n* the effect of single dose carbamazepine on the pk of single dose nevirapine\n* resistance against nevirapine before and after.\n* follow-up on HIV status newborns\n* relation between nevirapine levels in cord blood and plasma\n\nSecondary\n\n\\* safety of single dose nevirapine and nevirapine/carbamazepine\n\nHypothesis:\n\nSingle dose carbamazepine decreases development of resistance to nevirapine in HIV positive pregnant Tanzanian women by decreasing nevirapine half-life.', 'detailedDescription': 'Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is therefore standard of care in many African countries, like Tanzania. Recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV infected\n* antiretroviral naive\n* not intending to relocate out of area during study\n* willing to adhere to follow up scheme\n* ability and willing to give written consent\n* pregnant between 18 and 40 years\n* willing and able to regularly attend the Antenatal clinic\n\nExclusion Criteria:\n\n* serious illness that requires systemic treatment or hospitalization\n* any condition that would compromise subject's ability to participate\n* previously treated for HIV with antiretroviral agents, including single dose nevirapine used for MTCT\n* inability to understand the nature and extent of the trial and procedures"}, 'identificationModule': {'nctId': 'NCT00294892', 'briefTitle': 'Pharmacokinetics Study on Nevirapine Resistance in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)', 'orgStudyIdInfo': {'id': 'VITA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carbamazepine', 'description': 'An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery', 'interventionNames': ['Drug: carbamazepine and nevirapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nevirapine', 'description': 'Standard therapy of 200mg Nevirapine oral prior to delivery', 'interventionNames': ['Drug: Nevirapine']}], 'interventions': [{'name': 'carbamazepine and nevirapine', 'type': 'DRUG', 'description': 'Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.', 'armGroupLabels': ['Carbamazepine']}, {'name': 'Nevirapine', 'type': 'DRUG', 'description': 'Nevirapine 200mg is taken prior to delivery during labor.', 'armGroupLabels': ['Nevirapine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moshi', 'country': 'Tanzania', 'facility': 'Kilimanjaro Christian Medical College', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}], 'overallOfficials': [{'name': 'David M. Burger, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University (RUNMC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}