Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-03 @ 4:00 PM
Study NCT ID:
NCT01625169
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2012-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lspencer@usc.edu', 'phone': '323 226-6437', 'title': 'LaShonda Spencer', 'organization': 'USC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event reporting was collecting during the study and up through the last study visit.', 'description': 'There were no significant toxicities or adverse events attributable to Etravirine administration in any of the subjects who received study drug. Safety labs were obtained at D14 visit. No lab toxicities were observed.', 'eventGroups': [{'id': 'EG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'notes': 'One patient out of 9 (11%) reported diarrhea at the D5 PK visit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': '1 of 9 (11%) reported a self-resolving headache on D14; not likely to be related to ETR.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Tenderness', 'notes': '66% of the subjects complained of breast tenderness related to pumping.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Plasma Concentration of Etravirine in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '497.6', 'spread': '261.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'Cmax ng/ml\n\nNote: One participant did not complete the Day 5 evaluation.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: One participant did not complete the Day 5 evaluation.'}, {'type': 'PRIMARY', 'title': 'Peak Concentration of Etravirine in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '685.4', 'spread': '477.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 5', 'description': 'Cmax ng/ml\n\nNote: One participant did not complete the Day 5 evaluation.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: One participant did not complete the Day 5 evaluation.'}, {'type': 'PRIMARY', 'title': 'Peak Concentration of Etravirine in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '1805.4', 'spread': '1390.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 14', 'description': 'Cmax ng/mL', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: One participant did not complete the Day 14 evaluation.'}, {'type': 'PRIMARY', 'title': 'Peak Plasma Concentration of Etravirine in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '564.6', 'spread': '412.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 14', 'description': 'Cmax ng/mL', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: One participant did not complete the Day 14 evaluation.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) 0-12 for Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '3622.1', 'spread': '2020.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5: 0, 2,4, 8 and 24 hours post dose', 'description': 'AUC 0-12 ng\\*hr/ml', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete Day 5 visit.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) 0-12 for Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '4096', 'spread': '2999.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14: 0, 2,4, 8 and 24 hours post dose', 'description': 'AUC 0-12 ng\\*hr/ml', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete D14 visit.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) 0-12 for Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '4371.9', 'spread': '3491.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'AUC 0-12 ng\\*hr/ml', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete D5 visit.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) 0-12 for Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '12953.7', 'spread': '10200.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'AUC 0-12 ng\\*hr/ml', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete D14 visit.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load in Breast Milk and Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'title': 'Breast milk', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Plasma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5', 'description': 'Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete Visit D5.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load in Breast Milk and Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'classes': [{'title': 'Breast milk', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Plasma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete D14 visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV + Pregnant Women', 'description': 'Etravirine PK on days 5 and 14\n\nEtravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.\n\nThere is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous Pregnancies', 'classes': [{'title': 'Gravida', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Parity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Abortion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pregnancies', 'dispersionType': 'FULL_RANGE'}, {'title': 'Type of Delivery', 'classes': [{'title': 'C-section', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Vaginal', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Timing of Delivery', 'classes': [{'title': 'Term', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Preterm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'number participants'}, {'title': 'Previous Breast Feeding', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Data only available for 8 participants.', 'unitOfMeasure': 'participants'}, {'title': 'Absolute CD4 at Delivery', 'classes': [{'categories': [{'measurements': [{'value': '437', 'groupId': 'BG000', 'lowerLimit': '157', 'upperLimit': '913'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/ml', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2012-06-12', 'resultsFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-14', 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration of Etravirine in Plasma', 'timeFrame': 'Day 5', 'description': 'Cmax ng/ml\n\nNote: One participant did not complete the Day 5 evaluation.'}, {'measure': 'Peak Concentration of Etravirine in Breast Milk', 'timeFrame': 'day 5', 'description': 'Cmax ng/ml\n\nNote: One participant did not complete the Day 5 evaluation.'}, {'measure': 'Peak Concentration of Etravirine in Breast Milk', 'timeFrame': 'day 14', 'description': 'Cmax ng/mL'}, {'measure': 'Peak Plasma Concentration of Etravirine in Plasma', 'timeFrame': 'day 14', 'description': 'Cmax ng/mL'}, {'measure': 'Area Under the Curve (AUC) 0-12 for Plasma', 'timeFrame': 'Day 5: 0, 2,4, 8 and 24 hours post dose', 'description': 'AUC 0-12 ng\\*hr/ml'}, {'measure': 'Area Under the Curve (AUC) 0-12 for Plasma', 'timeFrame': 'Day 14: 0, 2,4, 8 and 24 hours post dose', 'description': 'AUC 0-12 ng\\*hr/ml'}, {'measure': 'Area Under the Curve (AUC) 0-12 for Breast Milk', 'timeFrame': 'Day 5', 'description': 'AUC 0-12 ng\\*hr/ml'}, {'measure': 'Area Under the Curve (AUC) 0-12 for Breast Milk', 'timeFrame': 'Day 14', 'description': 'AUC 0-12 ng\\*hr/ml'}], 'secondaryOutcomes': [{'measure': 'HIV Viral Load in Breast Milk and Plasma', 'timeFrame': 'Day 5', 'description': 'Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml'}, {'measure': 'HIV Viral Load in Breast Milk and Plasma', 'timeFrame': 'Day 14', 'description': 'Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'HIV', 'Breast milk'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'HIV positive pregnant women who receive potent combination antiretroviral therapy over at least the last trimester of pregnancy, and who have proper obstetric interventions and are able to avoid breast feeding, decrease the risk of having an infected infant to about 1%. Breast milk HIV-1 RNA (cell free) viral load is significantly associated with breast milk transmission, and a 2-fold increased risk of transmission associated with every 10-fold increase in breast milk viral load has been reported. In addition, cell associated virus (HIV DNA) was associated with a significant increase in risk of transmission independent of the level of cell-free viral RNA.\n\nHowever, multiple studies of HIV positive women giving birth have shown that exclusive breast-feeding carries a much lower risk of HIV transmission than mixed breast-feeding (defined as breast milk along with complementary food, other milk, and/or infant formula). The proposed study will measure the antiretroviral (ARV) drug etravirine concentrations in blood and breast milk in postpartum HIV positive women on HAART therapy. The short-term goal is to determine how much etravirine penetrates into breast milk, and whether it leads to undetectable HIV viral load in the breast milk and therefore has the potential to decrease the risk of transmission of HIV through breast milk. The long term goal is to see if breast milk HIV levels can be lowered sufficiently to prevent maternal to child transmission (MTCT) of HIV in infants receiving only breast feeding in resource poor areas.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. HIV+ pregnant women on HAART for the prevention of MTCT w/ undetectable viral load at time of delivery (w/i 30 days of delivery).\n2. 18 years and older\n3. Only women who are deemed by the physician as being capable of understanding that HIV positive women should not breastfeed will be approached.\n4. Life expectancy greater than 6 months\n5. No known allergies to etravirine\n6. Willingness of subject to adhere to protocol requirements.\n\nExclusion Criteria:\n\n1. Pregnant women with medical or psychological contraindications to breast milk expression.\n2. Requirements for prohibited medications:\n\n * ARV: Tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, and protease inhibitors administered without ritonavir, nonnucleoside reverse transcriptase inhibitor (NNRTIs).\n * Alternative/CAM: St. John's wort\n * Anticonvulsants: Phenobarbital, carbamazepine , phenytoin\n * Anti-infectives: Rifampin"}, 'identificationModule': {'nctId': 'NCT01625169', 'briefTitle': 'Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Antiretroviral Drug Concentrations and HIV Viral Load in Breast Milk and Plasma in HIV+ Women Receiving HAART (Highly Active Antiretroviral Therapy) Therapy: Etravirine (ETR) Pharmacokinetics (PK) in Breast Milk and Plasma', 'orgStudyIdInfo': {'id': 'HS-09-00698'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HIV + pregnant women', 'description': 'Etravirine pharmacokinetics in breast milk and plasma. Etravirine 200mg PO BID for 14 days with PK on days 5 and 14', 'interventionNames': ['Drug: Etravirine pharmacokinetics in breast milk and plasma']}], 'interventions': [{'name': 'Etravirine pharmacokinetics in breast milk and plasma', 'type': 'DRUG', 'description': 'HIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum. PK will be done on postpartum days 5 and 14.', 'armGroupLabels': ['HIV + pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC+USC MCA Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'LaShonda Y Spencer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Prof of Clinical Pediatrics', 'investigatorFullName': 'LaShonda', 'investigatorAffiliation': 'University of Southern California'}}}}