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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.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT01077557","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"","masked_caregiver":"","masked_investigator":"","masked_subject":"","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"","arm_groups":[{"arm_group_label":"No HIV infection","arm_group_description":"Subjects without HIV infection (Group 1) are adults, 18 years of age and older, continuously enrolled for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database, during the interval between January 1, 1997 and March 31, 2008, and with continuous eligibility for pharmacy benefits. A 3:1 match of subjects without HIV infection to a subject with HIV infection will occur. Each member of the comparator group without HIV infection will be matched on gender, month/year of IHCIS enrolment, and duration of enrollment to the respective study subject with HIV infection.","arm_type":""},{"arm_group_label":"HIV infection with no antiretroviral (ARV) drug exposure","arm_group_description":"HIV infection with no ARV drug exposure (Group 2) represents adults, 18 years of age and older, continuously enrolled for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database, during the interval between January 1, 1997 and March 31, 2008, and with continuous eligibility for pharmacy benefits. HIV exposure will be identified by ICD-9-CM code 042 or v08 in one or more diagnostic fields. This group will have no pharmacy dispensing for ARV drugs.","arm_type":""},{"arm_group_label":"HIV infection with ARV drug exposure","arm_group_description":"HIV infection with ARV drug exposure (Group 3) represents adults, 18 years of age and older, continuously enrolled for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database, during the interval between January 1, 1997 and March 31, 2008, and with continuous eligibility for pharmacy benefits. HIV exposure will be identified by ICD-9-CM code 042 or v08 in one or more diagnostic fields. This group will have at least one pharmacy dispensing for an HIV antiretroviral drug.","arm_type":""}],"assignment":"","brief_summary":"This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection. The objectives are to determine the incidence of fracture among persons with and without HIV infection, compare risk factors for fracture among persons with and without HIV infection, and to examine the associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture among persons with HIV infection.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Fractures stratified by HIV and Antiretroviral Therapy (ART) status","conditions":[{"DisplayValue":"Muscle, Bone & Joint - Other","DisplayValue_OneLinkTx":"","InternalValue":"CON_MUSCLE_BONE_JOINT_OTHER","LookupValue":"Fracture","LookupValue_OneLinkTx":""},{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:39:04","criteria":"Inclusion Criteria: - The inclusion criteria was continuous enrollment for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database during the interval between January 1, 1997 and March 31, 2008, age 18 years of age and older, and continuous eligibility for pharmacy benefits during IHCIS enrollment. Exclusion Criteria: - Exclusion criteria were membership in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database without a valid gender or age record, less than 12 months continuous enrolment, and member residence in the ‘national’ census region. This latter grouping represented members who were either not living in the continental US or were masked for confidentiality reasons based on IHCIS archiving of data per the Health Insurance Portability and Accountability Act.","detailed_description":"This study uses data from the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database. The study has two analytic components. The first is a retrospective cohort study comparing subjects without HIV infection to subjects with HIV infection for the incidence of and risk for fracture, including the use of anyARV drugs in persons with HIV infection. The second is a nested case-control study limited to persons with HIV infectiion within the cohort. Cases are those with incident fractures occurring after the diagnosis of HIV infection, and controls those without a fracture. Cases and controls will be compared for risk factors for incident fracture including ARV drug exposure. The drug exposures will include individual nucleoside reverse transcriptase inhibitors (NRTIs) (as permitted by sample size) and the other ARV drug classes. ViiV 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":"Both","display_gender_internal":"GENDER_ALL","display_phase":"","display_phase_internal":"","display_status":"Finalized","display_status_internal":"RECSTATUS_O_COMPLETED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"13594cd8-9918-5140-a344-f91043c3c2dc","internal":{"content":null,"contentDigest":"af72ef415d2d3a7e479e263ae0d757f9","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - The inclusion criteria was continuous enrollment for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database during the interval between January 1, 1997 and March 31, 2008, age 18 years of age and older, and continuous eligibility for pharmacy benefits during IHCIS enrollment. Exclusion Criteria: - Exclusion criteria were membership in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database without a valid gender or age record, less than 12 months continuous enrolment, and member residence in the ‘national’ census region. This latter grouping represented members who were either not living in the continental US or were masked for confidentiality reasons based on IHCIS archiving of data per the Health Insurance Portability and Accountability Act.","interventions":[{"arm_group_label":"No HIV infection","intervention_description":"No pharmacy dispensing of an ARV drug","intervention_name":"No Antiretroviral (ARV) Drug Exposure","intervention_type":"Other"},{"arm_group_label":"HIV infection with no antiretroviral (ARV) drug exposure","intervention_description":"No pharmacy dispensing of an ARV drug","intervention_name":"No Antiretroviral (ARV) Drug Exposure","intervention_type":"Other"},{"arm_group_label":"HIV infection with ARV drug exposure","intervention_description":"Pharmacy dispensing claim for any ARV drug","intervention_name":"Any Antiretroviral (ARV) Drug Exposure","intervention_type":"Drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Combivir (Zidovudine+Lamivudine)","Trizivir (Abacavir+Lamivudine+Zidovudine)","Zidovudine","Epzicom (Abacavir+Lamivudine)","Fracture","Amprenavir","human immunodeficiency virus (HIV) infection","antiretroviral (ARV) therapy","Lamivudine","incidence","Abacavir","risk","Fosamprenavir"],"last_follow_up_date":"11/01/2011 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"N/A N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"10/01/2018 22:21:13","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"None Retained","number_of_groups":"3","observational_study_design":"Case-Control","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"Fractures over time stratified by HIV infection and Antiretroviral Therapy (ART) exposure","org_study_id":"111950","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - 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":"","primary_compl_date":"11/01/2011 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Incident fracture defined by first ICD-9-CM code 733.1 or 800-829 during the follow-up period. Inclusion is restricted to four-digit codes for closed fracture. Exclusions will be codes for skull, face, chest, rib, open fracture, and crushing injuries","outcome_time_frame":"From enrollment in IHCIS National Managed Care Benchmarked Database to whichever of the following three event dates comes first: date of first fracture, end date of IHCIS enrollment, or March 31, 2008","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":"None","lead_sponsor":"ViiV Healthcare","collaborators":["GSK"]},"start_date":"11/01/2006 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"111950"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}