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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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Even with the introduction of many new ARV therapies, subjects routinely experience treatment failure due to numerous factors such as viral resistance, drug toxicity, and poor adherence. For the fostemsavir (GSK3684934) development program, the highly treatment experienced (HTE) subject population has been defined as those HIV-type 1 infected individuals who are failing their current ARV regimen, and have <2 classes of active ARVs which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing, tolerability and safety concerns. Little is known about the incidence, prevalence, and demographic characteristics of HTE HIV subjects. A real-world analysis focusing on the highly experienced HIV subjects and potential definitions of HTE will enlighten the understanding of the trends regarding the HTE population. An observational clinical cohort analysis utilizing prospectively collected electronic medical record (EMR) data obtained from the Opera Observational Database will be used to study incidence, prevalence, and demographic characteristics of HTE HIV subjects. The observational period for this study was 01-January-2012 through 31-December-2016.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Evaluation of the Incidence, Prevalence, Treatment and Demographic Characteristics of the Highly Treatment Experienced (HTE) HIV Positive Patient Population","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:25:38","criteria":"Inclusion Criteria: - A diagnosis of HIV-type 1, a positive HIV-type 1 Western Blot, or a positive HIV-type 1 enzyme-linked immunosorbent assay (ELISA); and a detectable HIV-type 1 viral load test - At least 18 years of age at the index date - Male, female, or transgender - ARV treatment experienced on or after January 1, 2012 Exclusion Criteria: - HIV negative subjects - HIV-type 2 positive subjects - HIV-type 1 positive, ARV treatment naïve subjects - HIV-type 1 positive, ARV treatment experienced subjects but have not initiated a second ARV treatment regimen by study end date","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Planned","display_status_internal":"RECSTATUS_O_PLANNED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"65f05e86-4918-54f2-bb77-3643e7cd6594","internal":{"content":null,"contentDigest":"342444ece0a779591e023e0422a6b328","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - A diagnosis of HIV-type 1, a positive HIV-type 1 Western Blot, or a positive HIV-type 1 enzyme-linked immunosorbent assay (ELISA); and a detectable HIV-type 1 viral load test - At least 18 years of age at the index date - Male, female, or transgender - ARV treatment experienced on or after January 1, 2012 Exclusion Criteria: - HIV negative subjects - HIV-type 2 positive subjects - HIV-type 1 positive, ARV treatment naïve subjects - HIV-type 1 positive, ARV treatment experienced subjects but have not initiated a second ARV treatment regimen by study end date","interventions":[{"arm_group_label":"ARV treatment-experienced HIV-type 1 positive subjects","intervention_description":"This study is an observational clinical cohort analysis of prospectively collected EMR data obtained from the OPERA Observational database. 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