{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/A4001068","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. 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":"<p>A unique number for a study given by ViiV.</p>"}},"ctGov":{"childMarkdownRemark":{"html":"<p>This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.</p>"}},"eudraCT":{"childMarkdownRemark":{"html":"<p>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.</p>"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT00719823","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"Non-randomized","arm_groups":[{"arm_group_label":"1","arm_group_description":"","arm_type":"Other"}],"assignment":"Single Group Assignment","brief_summary":"The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Maraviroc Compassionate Use","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Human Immunodeficiency Virus Type 1","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:46:05","criteria":"Inclusion Criteria: - Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen. - Have only CCR5-tropic HIV-1 virus - CD4+ cell count < 200 cells/mm3 Exclusion Criteria: - CXCR4- or dual/mixed-tropic HIV-1 virus - Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness - Patients who are pregnant or breast feeding an infant or planning to become pregnant.","detailed_description":"This study was cancelled prior to enrollment.","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 3","display_phase_internal":"PHASE_3","display_status":"Withdrawn","display_status_internal":"RECSTATUS_I_WITHDRAWN","endpoint":"","enrollment":"0","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"a79b94b9-c86d-54c4-8ce2-996180ffd735","internal":{"content":null,"contentDigest":"bfcbc05a5cf92ec8abedaf81ccb8f50b","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen. - Have only CCR5-tropic HIV-1 virus - CD4+ cell count < 200 cells/mm3 Exclusion Criteria: - CXCR4- or dual/mixed-tropic HIV-1 virus - Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness - Patients who are pregnant or breast feeding an infant or planning to become pregnant.","interventions":[{"arm_group_label":"1","intervention_description":"Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.","intervention_name":"Maraviroc","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["Maraviroc Compassionate Use"],"last_follow_up_date":"05/01/2010 00:00:00","links":[{"description":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001068&StudyName=Maraviroc%20Compassionate%20Use"}],"locations":[],"masking":"Open Label","maximum_age_raw":"N/A N/A","maximum_age":"N/A","minimum_age":"16","minimum_age_raw":"16 Years","modified_date":"10/01/2018 22:54:31","number_of_arms":"1","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Maraviroc Compassionate Use","org_study_id":"A4001068","overall_contact":{"email":null,"last_name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021"},"overall_status":"Withdrawn - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 3","primary_compl_date":"05/01/2010 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Safety analysis will include all subjects who receive at least one dose of study drug","outcome_time_frame":"Two Years","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Safety analysis will include all subjects who receive at least one dose of study drug","outcome_time_frame":"Two years","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"None","lead_sponsor":"ViiV Healthcare","collaborators":["Pfizer"]},"start_date":"08/01/2008 00:00:00","study_type":"Interventional","therapeutic_area":"","citations":[],"is_section_801":true}},"pageContext":{"studyId":"A4001068"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}