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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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Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.","IpdDescription":"IPD for this study will be made available via the Clinical Study Data Request Site","IpdInfoTypeAnalyticCode":"No","IpdInfoTypeIcf":"Yes","IpdInfoTypeCsr":"Yes","IpdInfoTypeProtocol":"Yes","IpdInfoTypeSap":"Yes","IpdTimeFrame":"IPD will be made available within 6 months of publishing the results of the primary endpoints of the study","IpdUrl":"http://clinicalstudydatarequest.com","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"","masked_caregiver":"","masked_investigator":"","masked_subject":"","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"Yes","acronym":"","allocation":"","arm_groups":[{"arm_group_label":"HIV positive pregnant women","arm_group_description":"Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included.","arm_type":""}],"assignment":"","brief_summary":"The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. The enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. The data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Study to define Safety and effectiveness of Dolutegravir (DTG) use in Human Immunodeficiency Virus (HIV) positive pregnant women","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"05/20/2020 14:10:50","criteria":"Inclusion Criteria:\n - HIV positive pregnant women aged 18 years and over on DTG\n - With no maternal or birth outcomes yet\n - Subjects are able and willing to provide written informed consent and comply with any safety reporting requirements.\n\nExclusion Criteria:\n -","detailed_description":"","display_gender":"Female","display_gender_internal":"GENDER_FEMALE","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Ongoing","display_status_internal":"RECSTATUS_O_ONGOING","endpoint":"","enrollment":"250","exclusion":"","gender":"Female","gender_based":"Yes","gender_description":"HIV positive pregnant women","healthy_volunteers":"No","id":"b7522052-420d-57d2-bf8b-bfbc97c7ed52","internal":{"content":null,"contentDigest":"b24b871480303d9d0c4f7ca610053dd4","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - HIV positive pregnant women aged 18 years and over on DTG\n - With no maternal or birth outcomes yet\n - Subjects are able and willing to provide written informed consent and comply with any safety reporting requirements.\n\nExclusion Criteria:\n -","interventions":[{"arm_group_label":"HIV positive pregnant women","intervention_description":"Subjects with DTG exposure during any trimester will be included","intervention_name":"DTG","intervention_type":"Drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["HIV","Dolutegravir","Europe","NEAT ID","pregnancy","Safety","Antiretroviral"],"last_follow_up_date":"04/28/2023 00:00:00","links":[],"locations":[{"City":"Barcelona","Latitude":"41.4182256","CountryDisplay":"Spain","Longitude":"2.1769564","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"08041","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"05/20/2020 14:10:50","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"None Retained","number_of_groups":"1","observational_study_design":"Cohort","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Prospective"},"official_title":"DOLOMITE NEAT ID Network Study: A prospective, multi-site observational study to define the safety and effectiveness of Dolutegravir use in HIV positive pregnant women","org_study_id":"208759","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Recruiting - Observational","oversight_info":{"exported_from_us":"","fda_regulated_device":"No","fda_regulated_drug":"Yes","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 4","primary_compl_date":"09/17/2021 00:00:00","primary_outcomes":[{"outcome_description":"Spontaneous abortion is defined as death of a fetus or expulsion of the products of conception before 22 weeks gestation.","outcome_measure":"Number of female subjects with spontaneous abortion","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.","outcome_measure":"Number of female subjects with induced abortion","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Still birth is defined as the death of a fetus occurring at 22 weeks of gestation or more, or for situations in which the gestational age is unavailable, a fetus weighing at least 500 grams.","outcome_measure":"Number of female subjects giving still births","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Number of female subjects giving multiple births will be reported.","outcome_measure":"Number of female subjects with multiple births","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"The different type of deliveries will be summarized.","outcome_measure":"Number of female subjects with type of deliveries","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"The maternal viral load at the time of delivery will be summarized.","outcome_measure":"Maternal viral load (VL) at delivery","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Birth defects will be classified according to World Health Organization’s International Classification of Diseases, Tenth Revision.","outcome_measure":"Number of infants with birth defects","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Number of females with birth collected data for gestational age as a measure of birth defects will be reported.","outcome_measure":"Gestational age","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Number of females with birth collected data for birth weight as a measure of birth defects will be reported.","outcome_measure":"Birth weight","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Premature birth is defined as birth of live infant at <32 weeks gestation","outcome_measure":"Number of female subjects giving premature births","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Number of female subjects giving live births will be reported.","outcome_measure":"Number of female subjects giving live births","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Low birth weight is defined as birth weight of <2500 grams.","outcome_measure":"Infants with low birth weight","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"APGAR score in infants as a measure of birth defects will be calculated.","outcome_measure":"Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Infant’s HIV status as a measure of birth defects will be reported.","outcome_measure":"HIV status of Infants","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null}],"product_name":"GSK3365791;abacavir;dolutegravir;dolutegravir/abacavir/lamivudine;dolutegravir/lamivudine;lamivudine;rilpivirine","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Number of females with all drug related Adverse Events and Serious Adverse Events will be reported. These will be categorized by trimester of initiation.","outcome_measure":"Number of female subjects with drug related Adverse Events and Serious Adverse Events","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Number of pregnant females with discontinuation of DTG will be reported.","outcome_measure":"Rate of DTG discontinuation in pregnant women","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"Reasons for DTG discontinuation will be summarized. Number of participants who discontinued DTG will be reported.","outcome_measure":"Number of participants who discontinued DTG","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null},{"outcome_description":"VL at discontinuation will be summarized to assess suppression. Number of participants with VL at discontinuation will be reported.","outcome_measure":"Number of participants with VL at discontinuation","outcome_time_frame":"Up to 1 year","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"11/18/2019 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"208759"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}