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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
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There are no well-controlled studies evaluating the use of dolutegravir in pregnant women. This is a retrospective analysis of individual patient data prospectively (exposure data collected before outcome is known) collected in cohort and surveillance studies of pregnant women living with HIV and their infants from several countries, primarily those within European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC), and supplemented by patient data collected in the NEAT-ID network and obstetric sites participating in the pharmacokinetics of newly developed ARV in HIV-infected pregnant women participants (PANNA) study. This analysis aims to assess maternal outcomes following prenatal exposure to dolutegravir (TIVICAY^® and TRIUMEQ^®) reported to participating studies by end August 2016 and fetal outcomes. TIVICAY and TRIUMEQ are registered trademark of the ViiV Healthcare and the GlaxoSmithKline group of companies","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC)","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:20:23","criteria":"Inclusion Criteria: - All HIV-positive pregnant women participants aged 18 years and above, with any exposure to dolutegravir (TIVICAY & TRIUMEQ) at any time during the pregnancy reported to participating studies by end August 2016 and their infants will be included Exclusion Criteria: - None","detailed_description":"","display_gender":"Female","display_gender_internal":"GENDER_FEMALE","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Finalized","display_status_internal":"RECSTATUS_O_COMPLETED","endpoint":"","enrollment":"1","exclusion":"","gender":"Female","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"5d2cbd18-a911-5c9d-93aa-4839669f3f24","internal":{"content":null,"contentDigest":"d033ae05bfb167c66a3394531101186b","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - All HIV-positive pregnant women participants aged 18 years and above, with any exposure to dolutegravir (TIVICAY & TRIUMEQ) at any time during the pregnancy reported to participating studies by end August 2016 and their infants will be included Exclusion Criteria: - None","interventions":[{"arm_group_label":"Pregnant, HIV positive women participants","intervention_description":"Women participants will receive TIVICAY or TRIUMEQ as prescribed (Dosage will vary for each participant)","intervention_name":"Dolutegravir","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["dolutegravir","HIV","pregnancy","EPPICC"],"last_follow_up_date":"07/28/2017 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"18Years","minimum_age_raw":"18Years","modified_date":"10/01/2018 22:44:22","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"0","observational_study_design":"Case-Control","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Prospective"},"official_title":"Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC)","org_study_id":"206254","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - 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