{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/A4001031","result":{"data":{"studyNotFoundJson":{"title":"Study not found","content":{"childMarkdownRemark":{"html":"<p>If you entered a web address please check it was correct.</p>\n<p>You can also try <a href=\"/en/studies\">Search Page</a> to find the study you are looking for.</p>"}}},"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. 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This study will also determine whether maraviroc is safe to use in children and adolescents.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:23:39","criteria":"Inclusion Criteria: - Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL Exclusion Criteria: - X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay - Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs) - Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase; - Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST < 2.5 X ULN; No symptoms other than jaundice or icterus. - Other laboratory values ≥Grade 3, must be reviewed by Pfizer.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 2","display_phase_internal":"PHASE_2","display_status":"Active, not recruiting","display_status_internal":"RECSTATUS_I_ACTIVE_NOT_REC","endpoint":"","enrollment":"103","exclusion":"","gender":"Both","gender_based":"No","gender_description":"","healthy_volunteers":"No","id":"dae6bbde-2df0-5582-8010-effcaa06ce23","internal":{"content":null,"contentDigest":"9e0365e131745514339bdd7c189744bc","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL Exclusion Criteria: - X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay - Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs) - Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase; - Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST < 2.5 X ULN; No symptoms other than jaundice or icterus. - Other laboratory values ≥Grade 3, must be reviewed by Pfizer.","interventions":[{"arm_group_label":"Maraviroc","intervention_description":"Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. 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