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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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The purpose of the APR is to detect any major teratogenic effects involving any of the Registry drugs when administered to pregnant HIV positive women. The Registry is intended to provide an early signal of teratogenicity associated with prenatal use of the antiretroviral drugs. The Registry collects data on prenatal exposures to antiretroviral drugs, potential confounding factors (such as maternal age, disease status during pregnancy), and information about the outcome of the pregnancy.\nThe Registry is managed by INC Research. The scientific conduct and analysis of the Registry data are overseen by an independent Advisory Committee consisting of members from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the academic sector. Registry data are obtained from participating providers who encompass physicians in private practice as well as hospitals and community clinics. \n\nThe registry is co-sponsored and co-funded by 26 pharmaceutical companies that manufacture drugs used in ART.\n\nFor an updated version of the registry, please see NCT00404989.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Antiretroviral Pregnancy Registry (APR)-Risk of birth defects","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:32:35","criteria":"Inclusion Criteria:\n - Any pregnant, HIV positive woman exposed to antiretroviral drugs during pregnancy.","detailed_description":"The Registry conforms to the FDA Guidance for Industry: Establishing Pregnancy Exposure Registries, the Guidelines for Good Pharmacoepidemiology Practices, and the FDA Guidance on Pharmacovigilance. \nThe Antiretroviral Pregnancy Registry collects data on use of the following GSK drugs: abacavir, amprenavir, delavirdine, fosamprenavir, lamivudine, maraviroc, zidovudine, and their combinations during pregnancy. The Registry requests information from medical providers about antiretroviral therapy, though there may be other drug exposures, which are not systematically collected. \n\nRegistration is voluntary. Health professionals are strongly encouraged to enroll their antiretroviral-exposed pregnant patients into the Registry as early in the pregnancy as possible, preferably before prenatal testing is done. This is to maximize the data validity by minimizing potential biases introduced when a woman is enrolled after prenatal testing.\n\nPatients are followed through health care providers who provide information on maternal risk factors, pregnancy outcome, and neonatal health. In the month of expected delivery, a short follow-up form is sent to the health care provider to ascertain the pregnancy outcome and completion of the antiviral therapy information. Additional follow-up is not sought from health care providers. \n\nIn an attempt to limit the bias in the analysis, the Registry assembled a group of providers who committed in writing to report every woman who receives antiretroviral therapy during pregnancy, but before the pregnancy outcome is known, that comes to their site. This allows the Registry to include every report from that site as an evaluable case. As the number of cases from these sites increases, the Registry will be able to analyze those cases separately. Providers are encouraged to participate in this group.\n\n\n\nViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.","display_gender":"Female","display_gender_internal":"GENDER_FEMALE","display_phase":"N/A","display_phase_internal":"PHASE_NA","display_status":"Ongoing","display_status_internal":"RECSTATUS_O_ONGOING","endpoint":"","enrollment":"1","exclusion":"","gender":"Female","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"f39ef999-60f6-5521-9a82-2e9a30439409","internal":{"content":null,"contentDigest":"495d479934986196262ef28a73122f72","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - Any pregnant, HIV positive woman exposed to antiretroviral drugs during pregnancy.","interventions":[{"arm_group_label":"Pregnant, HIV Positive Women","intervention_description":"Any exposure to an antiretroviral therapy: Abacavir, Amprenavir, Delavirdine, Fosamprenavir, Lamivudine, Maraviroc, Zidovudine, Combivir (Zidovudine+Lamivudine), Epzicom (Abacavir+Lamivudine), and/or Trizivir (Abacavir+Lamivudine+Zidovudine)","intervention_name":"Any Antiretroviral Therapy","intervention_type":"Drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Combivir (Zidovudine+Lamivudine)","Antiretrovirals","ARV","HAART","Maraviroc","Delavirdine","Lamivudine","Antiretroviral Pregnancy Registry","Fosamprenavir","APR","Zidovudine","pregnancy registry","Amprenavir","HIV","Trizivir (Abacavir+Lamivudine+Zidovudine)","Epzicom (Abacavir+Lamivudine)"],"last_follow_up_date":"12/31/2024 00:00:00","links":[{"description":"Click Here to See Preliminary Results on ViiV Healthcare's Clinical Study Register","url":"https://www.viiv-clinicalstudyregister.com/study/112885_8?search=study&search_terms=112885#rs"}],"locations":[{"City":"Wilmington","Latitude":"34.2426224","CountryDisplay":"United States","Longitude":"-77.8252923","Name":"GSK Investigational Site","StateDisplay":"North Carolina","PostalCode":"28405","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"N/A","minimum_age_raw":"N/A","modified_date":"08/21/2019 21:40:09","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"None Retained","number_of_groups":"1","observational_study_design":"Other","patient_registry":"true","target_duration_quantity":"31","target_duration_units":"Years","timing":"Prospective"},"official_title":"Antiretroviral Pregnancy Registry (APR)-Risk of birth defects associated with exposure to GSK HIV drugs during pregnancy","org_study_id":"112885","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":"No","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"N/A","primary_compl_date":"12/31/2024 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"A birth defect is defined as any congenital malformations according to modified (by APR) classification of Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria","outcome_time_frame":"Birth defect is to be diagnosed in fetuses of at least 20 weeks gestational age through children of up to 6 years of age","outcome_safety_issue":null}],"product_name":"abacavir;abacavir/lamivudine;abacavir/lamivudine/zidovudine;amprenavir;delavirdine;dolutegravir;dolutegravir/abacavir/lamivudine;fosamprenavir;lamivudine;lamivudine/zidovudine/maraviroc;maraviroc;maraviroc;zidovudine;zidovudine/lamivudine","product_name_OneLinkTx":"","secondary_ids":[{"id":"WE066 (EPIP095)","id_type":"Other Identifier","id_domain":"GSK"},{"id":"EPI40018","id_type":"Other Identifier","id_domain":"GSK"}],"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":["GlaxoSmithKline","GSK","INC Research"]},"start_date":"02/15/1993 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[{"citation":"The Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy registry International Interim report for 1 January 1989 through 31 January 2010. Wilmington, NC: Registry Coordinating Center; 2010. Available from URL: www.APRegistry.com","is_results_ref":"No","pubmed_id":""},{"citation":"Vannappagari V, Koram N, Albano J, et al.Abacavir and lamivudine exposures during pregnancy and non-defect adverse pregnancy outcomes: data from the antiretroviral pregnancy registry .Jaids-J Acq Imm Def.2015;68(3):359-64","is_results_ref":"","pubmed_id":""}],"is_section_801":null}},"pageContext":{"studyId":"112885"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}