{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/A4001082","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":"NCT00666705","ctis_id":"","HasResults":"true","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"","masked_caregiver":"","masked_investigator":"","masked_subject":"","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"Nonrandomized Trial","arm_groups":[{"arm_group_label":"Maraviroc alone","arm_group_description":"","arm_type":"Experimental"},{"arm_group_label":"Maraviroc + Raltegravir","arm_group_description":"","arm_type":"Experimental"},{"arm_group_label":"Raltegravir alone","arm_group_description":"","arm_type":"Experimental"}],"assignment":"Single Group","brief_summary":"An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects","conditions":[{"DisplayValue":"Other","DisplayValue_OneLinkTx":"","InternalValue":"CON_OTHER","LookupValue":"Healthy","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:53:23","criteria":"Inclusion Criteria: - Healthy male and/or female subjects between 18 and 55 years of age. Exclusion Criteria: - Evidence or history of clinically significant disease or clinical findings at screening","detailed_description":"Drug interaction study","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"18","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"Yes","id":"d34ec3ce-a746-582a-adab-1b93433cb423","internal":{"content":null,"contentDigest":"159ce2b1ee22ee934f27a0d19481c21b","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Healthy male and/or female subjects between 18 and 55 years of age. Exclusion Criteria: - Evidence or history of clinically significant disease or clinical findings at screening","interventions":[{"arm_group_label":"Maraviroc alone","intervention_description":"300 milligrams(mg) every 12 hours Days 6-11","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"Maraviroc + Raltegravir","intervention_description":"Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"Maraviroc + Raltegravir","intervention_description":"Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)","intervention_name":"Raltegravir","intervention_type":"Drug"},{"arm_group_label":"Raltegravir alone","intervention_description":"400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5","intervention_name":"Raltegravir","intervention_type":"Drug"}],"interventional_subtype":"Other","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["maraviroc","raltegravir","drug interaction study","healthy volunteers"],"last_follow_up_date":"03/01/2008 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=A4001082&StudyName=A%20Study%20To%20Evaluate%20An%20Interaction%20Between%20Maraviroc%20And%20Raltegravir%20In%20Healthy%20Subjects"},{"description":"Link to ClinicalStudyResults.org","url":"http://www.clinicalstudyresults.org/drugdetails/?study_name=A4001082&sort=c.company_name&page=1&drug_id=8691"}],"locations":[{"City":"New Haven","Latitude":"41.3212912","CountryDisplay":"United States","Longitude":"-72.9283391","Name":"Pfizer Investigational Site","StateDisplay":"CT","PostalCode":"06511","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"Open","maximum_age_raw":"55 Years","maximum_age":"55","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"10/01/2018 22:55:07","number_of_arms":"3","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects","org_study_id":"A4001082","overall_contact":{"email":null,"last_name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021"},"overall_status":"Completed - 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 4","primary_compl_date":"03/01/2008 00:00:00","primary_outcomes":[],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":null,"outcome_measure":null,"outcome_time_frame":null,"outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"None","lead_sponsor":"ViiV Healthcare","collaborators":["Pfizer"]},"start_date":"02/01/2008 00:00:00","study_type":"Interventional","therapeutic_area":"","citations":[],"is_section_801":true}},"pageContext":{"studyId":"A4001082"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}