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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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"}},"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.
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There is limited information on the long term impact of MVC use in subjects with HIV in Portugal. This observational, prospective study aims to evaluate the effectiveness, safety, tolerability and Quality of life (QoL) in HIV-1 subjects who will initiate MVC with Optimized Background Antiretroviral Therapy (OBT). Approximately, 106 subjects who will be initiating MVC with OBT will be included in the study in a prospective manner along with retrospective inclusion of approximately 44 subjects who had previously initiated MVC with OBT and subjects who discontinued MVC prior to inclusion. The data obtained from medical records and subject’s interview will be recorded in a web-based questionnaire. The estimated duration of the study is approximately 2.5 years.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"A multicentre observational study to evaluate the effectiveness, safety and treatment costs of maraviroc used with optimized background therapy in treatment-experienced HIV infected patients in routine clinical practice in Portugal","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 20:20:51","criteria":"Inclusion Criteria: - HIV-1 infected male or female subjects, 18 years of age or older at the time of inclusion. - Antiretroviral treatment-experienced subjects. - Subjects who received an appropriate tropism assay as a screening for eligibility to receive Maraviroc (either genotypic or phenotypic testing). - Subjects who will initiate treatment with MVC plus OBT, according to investigator’s decision-scenario A or subjects who had initiated treatment with MVC plus OBT prior to enrolment in the study- scenario B (not necessarily on this regimen at the time of enrolment in the study. - The subject’s treatment in accordance with the Summary of Product Characteristics (SPC) of MVC. - Subject (or legally acceptable representative) who provided the signed and dated informed consent to allow for data collection. Exclusion Criteria: - Female subjects who are pregnant, lactating, or whom are planning to become pregnant (scenario A) or were pregnant by the time MVC + OBT introduction (scenario B). - Subjects who are hypersensitive to the active substance or to peanut or soya or to any of the excipients, or any other contraindication according to SPC. - Subjects who had participated in an interventional study during the Observation Period (scenario B).","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Finalized","display_status_internal":"RECSTATUS_O_COMPLETED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"none","id":"badcd060-e6d9-592a-b08c-8ba834b2220c","internal":{"content":null,"contentDigest":"4aaf511ee2e721dbab6d89a4d36f37ca","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - HIV-1 infected male or female subjects, 18 years of age or older at the time of inclusion. - Antiretroviral treatment-experienced subjects. - Subjects who received an appropriate tropism assay as a screening for eligibility to receive Maraviroc (either genotypic or phenotypic testing). - Subjects who will initiate treatment with MVC plus OBT, according to investigator’s decision-scenario A or subjects who had initiated treatment with MVC plus OBT prior to enrolment in the study- scenario B (not necessarily on this regimen at the time of enrolment in the study. - The subject’s treatment in accordance with the Summary of Product Characteristics (SPC) of MVC. - Subject (or legally acceptable representative) who provided the signed and dated informed consent to allow for data collection. Exclusion Criteria: - Female subjects who are pregnant, lactating, or whom are planning to become pregnant (scenario A) or were pregnant by the time MVC + OBT introduction (scenario B). - Subjects who are hypersensitive to the active substance or to peanut or soya or to any of the excipients, or any other contraindication according to SPC. - Subjects who had participated in an interventional study during the Observation Period (scenario B).","interventions":[{"arm_group_label":"Subjects with HIV-1","intervention_description":"A specifically designed web-based questionnaire will be used to collect Baseline, follow-up and final disposition data for each included subject. 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48","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with adverse events (AEs) and serious adverse events (SAEs)","outcome_time_frame":"Up to Week 48","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with grade 3 or 4 hepatotoxicity","outcome_time_frame":"Up to Week 48","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with plasma HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (mL)","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Mean change from Baseline in serum creatinine or calculated creatinine clearance","outcome_time_frame":"Baseline and Up to Week 48","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with documented viral resistance","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Number of subjects with abnormal laboratory values","outcome_time_frame":"Up to 2.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in International HIV Dementia Scale (IHDS)","outcome_time_frame":"Baseline and Weeks 12, 24, 48 and 96","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Mean change from Baseline in serum creatinine or calculated creatinine clearance","outcome_time_frame":"Baseline and Up to 2.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in elicit utility values for potential cost effectiveness assessment (EQ-5D) score","outcome_time_frame":"Baseline and Weeks 12, 24, 48 and 96","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Mean and percent mean 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years","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["Eurotrials"]},"start_date":"02/01/2012 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"115647"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}