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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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EPPICC is a network of European cohorts of prospectively observed mother-child pairs and children within EuroCoord. There are no adequate and well-controlled studies evaluating the use of dolutegravir (DTG) in pregnant women. This analysis aims to assess maternal and fetal outcomes following DTG use during pregnancy. The primary objective of the study is to describe trends and patterns of use of DTG-containing regimens in pregnancy in Europe, including timing of initiation, nucleoside reverse transcriptase inhibitor (NRTI) backbone and geographic/calendar time trends (including future use of DTG-containing two drug regimens).","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"DOLOMITE EPPICC Study: 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":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 18:11:23","criteria":"Inclusion Criteria: - All pregnant women with any exposure to DTG at any time during the pregnancy and their infants will be included in the analysis. Exclusion Criteria: - NA","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"N/A","display_phase_internal":"PHASE_NA","display_status":"Planned","display_status_internal":"RECSTATUS_O_PLANNED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"74b27f4a-fb93-5394-9498-0bbff8a58ab5","internal":{"content":null,"contentDigest":"c62acdbf66cb3fcbfdb4d214cf2a7064","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - All pregnant women with any exposure to DTG at any time during the pregnancy and their infants will be included in the analysis. Exclusion Criteria: - NA","interventions":[{"arm_group_label":"Subjects receiving DTG","intervention_description":"Dolutegravir (DTG) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection.","intervention_name":"Dolutegravir (DTG)","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["DTG","Adverse pregnancy outcomes","Fetus","DOLOMITE EPPICC","Pregnancy","HIV"],"last_follow_up_date":"12/31/2022 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":null,"minimum_age_raw":"","modified_date":"10/01/2018 22:48:13","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"0","observational_study_design":"Cohort","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"DOLOMITE EPPICC Study: Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC)","org_study_id":"208613","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Not yet recruiting - Observational","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"N/A","primary_compl_date":"12/31/2022 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Number of subjects with pregnancy outcomes by trimester of exposure to DTG","outcome_time_frame":"Up to 9 months","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with adverse pregnancy outcomes by trimester of exposure to DTG","outcome_time_frame":"Up to 9 months","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with maternal virological suppression at the end of pregnancy","outcome_time_frame":"Up to 9 months","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Mother-to-child transmission (MTCT) rates in mother-infant pairs with prenatal DTG use","outcome_time_frame":"Up to 9 months","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":null,"outcome_measure":null,"outcome_time_frame":null,"outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A"]},"start_date":"03/23/2018 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"208613"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}