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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 term cART is used to designate a combination therapy designed to achieve maximum suppression of the viral burden. HIV infection is now considered a chronic disease for which effective therapies are available rather than a disease with poor prognosis1,2. Celsentri (or Selzentry® - drug substance: maraviroc) was the first antiretroviral drug in the CCR5 receptor antagonist class to obtain a marketing authorization (MA) in Europe. The marketing authorization was granted by the European Medicines Agency on 18 September 2007. Maraviroc, in combination with other antiretroviral drugs, is indicated in the treatment of HIV infection with detected CCR5 tropism only in adults pretreated with antiretrovirals. On 11 June 2008, the Transparency Commission of the French High Authority for Health (HAS) formulated a favorable opinion on the inclusion of maraviroc on the list of proprietary medicinal products reimbursed for patients with social security coverage and on inclusion on the list of medicinal products accredited for use by collective institutions and miscellaneous public services. Viral tropism determination is necessary prior to maraviroc treatment since the latter is not effective for patients infected by viruses with tropisms other than R5, CXCR4 tropism or double/mixed tropism viruses. Phenotypic tropism tests and genotypic tropism tests have been recommended by the HAS since 2009. Evaluation of the public health value of maraviroc thus necessitates both data on HIV-1 tropism determination and long-term follow-up data.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Protocol to evaluate the public health value of maraviroc using the French hospital databaseon HIV infection (FHDH)","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 20:25:09","criteria":"Inclusion Criteria: - HIV infection (HIV-1 and/or HIV-2), follow-up in a center participating in the FHDH database, and written informed consent. - Male or female patients aged more than 18 years - HIV-1 patients followed up in the database between 1 January 2008 and 30 June 2011 Exclusion Criteria: - Patients taking part in a double-blind clinical trial.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"N/A","display_phase_internal":"PHASE_NA","display_status":"Ongoing","display_status_internal":"RECSTATUS_O_ONGOING","endpoint":"","enrollment":"700","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"none","id":"f27f90ba-0fac-518e-91b9-2987f19f7851","internal":{"content":null,"contentDigest":"78ab4b5f0a03d02c96655538bdf3dc84","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - HIV infection (HIV-1 and/or HIV-2), follow-up in a center participating in the FHDH database, and written informed consent. - Male or female patients aged more than 18 years - HIV-1 patients followed up in the database between 1 January 2008 and 30 June 2011 Exclusion Criteria: - Patients taking part in a double-blind clinical trial.","interventions":[{"arm_group_label":"maraviroc use","intervention_description":"use in current practice","intervention_name":"maraviroc","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":[],"last_follow_up_date":"01/01/2013 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"18","minimum_age_raw":"18 Year","modified_date":"10/01/2018 22:30:32","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"","observational_study_design":"Cohort","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"Protocol to evaluate the public health value of maraviroc using the French hospital databaseon HIV infection (FHDH)","org_study_id":"116483","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":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":null,"post_prior_to_approval":"","regulatory_authorities":["France: GSK observational study","France: Commission Nationale Informatique et Libertés"]},"phase":"n\\a","primary_compl_date":"07/01/2012 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"• to describe the HIV-1 patients treated with maraviroc","outcome_time_frame":"2008-2011","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"to describe the tropism tests conducted prior to maraviroc prescription","outcome_time_frame":"2008-2011","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GSK"]},"start_date":"01/23/2012 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"116483"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}