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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 circumstances impacting the female with HIV are: differences in drug metabolism, childbearing, care giving, abuse, increased risk of autoimmunity, hypertension, diabetes, menopause, mental status changes, bone loss etc. These circumstances may interfere with chosen treatment strategies as well as short-term and long-term adherence. The newer regimens offer both improved dosing frequency and reduced pill count which may prove to be especially important when designing treatment strategies for those with complex life circumstances such as women living with HIV. Evaluating the clinical success of these newer regimens, especially in women, requires further exploration. This study is an observational study utilizing prospectively collected electronic medical record (EMR) data obtained from the Observational Pharmaco-Epidemiology Research and Analysis (OPERA) Database which will be used to describe the baseline demographic and clinical characteristics, and to compare regimen durability and virologic suppression and failure in female HIV+ participants. 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Exclusion Criteria: - Male - HIV negative - A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multispot, a positive HIV-2-specific ELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test. - Initial INSTI treatment identified as a component of post exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP)","detailed_description":"","display_gender":"Female","display_gender_internal":"GENDER_FEMALE","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Planned","display_status_internal":"RECSTATUS_O_PLANNED","endpoint":"","enrollment":"1","exclusion":"","gender":"Female","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"be13022f-0f1e-5941-b32f-49290572978a","internal":{"content":null,"contentDigest":"ace412bba79095e9b9bd9fa896119e76","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Female - A diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1 enzyme-linked immunosorbent assay (ELISA); and a detectable HIV-1 viral load test. - At least 13 years of age at the index date. - At least one HIV-1 viral load test and one CD4 lymphocyte test on or up to 120 days prior to index date. - Continuous clinical activity in the year prior to INSTI initiation, defined as at least one clinic visit. - Continuous clinical activity in the year following INSTI initiation, defined as at least one clinical contact (visit or telephone contact). 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