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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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Current or recent (within 3 months) gastrointestinal disease that, in the opinion of Investigator or Medical Monitor, may impact on drug absorption and/or put subject at risk for GI tract irritation and/or bleeding. - Acute diarrhea lasting ≥ 1 day, within 3 weeks prior to randomization. - Major surgery within 4 weeks of study drug intake. - Gastrointestinal surgery that could impact upon absorption of study drug. - Donation of blood or plasma to blood bank or in a clinical study (except a Screening visit or follow up visit of less than 50 mL) within 4 weeks of study drug intake. - Blood transfusion within 4 weeks of study drug intake. - Inability to tolerate oral medication. - Inability to be venipunctured and/or tolerate venous access. - Personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes. - Personal or family history of long QT syndrome. - Recent (within 6 months) drug/alcohol abuse - Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation. - Evidence of organ dysfunction or clinically significant deviation from normal in physical examination, vital signs, ECG or clinical lab determinations or not consistent with subject's degree of HIV infection. - Evidence of 2nd or 3rd degree heart block at screening or Day -1 - Positive urine drug screen at Screening or Day -1 without valid prescription (subjects positive for cannabinoids and/or amphetamines will be included). - Positive blood screen for hepatitis B surface antigen. - Positive blood screen for hepatitis C antibody and hepatitis C RNA. - History of significant drug allergy - Exposure to any investigational drug or placebo within 4 weeks of study drug intake. - Prescription drugs within 4 weeks prior to study drug intake, unless approved by BMS medical monitor. - Other drugs, including over-the-counter medications, vitamins and/or herbal preparations, within 1 week prior to study drug intake, unless approved by BMS medical monitor. - 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Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation. - Evidence of organ dysfunction or clinically significant deviation from normal in physical examination, vital signs, ECG or clinical lab determinations or not consistent with subject's degree of HIV infection. - Evidence of 2nd or 3rd degree heart block at screening or Day -1 - Positive urine drug screen at Screening or Day -1 without valid prescription (subjects positive for cannabinoids and/or amphetamines will be included). - Positive blood screen for hepatitis B surface antigen. - Positive blood screen for hepatitis C antibody and hepatitis C RNA. - History of significant drug allergy - Exposure to any investigational drug or placebo within 4 weeks of study drug intake. - Prescription drugs within 4 weeks prior to study drug intake, unless approved by BMS medical monitor. - Other drugs, including over-the-counter medications, vitamins and/or herbal preparations, within 1 week prior to study drug intake, unless approved by BMS medical monitor. - Use of oral, injectable or implantable hormonal contraceptive agent within 12 weeks of study drug intake. - Use of prescription drugs or OTC drugs that may cause GI tract irritation or bleeding within 2 weeks of study drug intake, unless approved by BMS medical monitor. - Use of alcohol-containing beverages within 3 days prior to study drug intake. - Use of grapefruit, grapefruit-containing or Seville orange-containing products within 7 days prior to study drug intake. - Prisoners or subjects involuntarily incarcerated. - Subjects compulsorily detained for treatment of either a psychiatric or physical illness.","interventions":[{"arm_group_label":"Group 4","intervention_description":"8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H","intervention_name":"BMS-663068 with or without ritonavir","intervention_type":"Drug"},{"arm_group_label":"Group 2","intervention_description":"8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H","intervention_name":"BMS-663068 with or without ritonavir","intervention_type":"Drug"},{"arm_group_label":"Group 1","intervention_description":"8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H","intervention_name":"BMS-663068 with or without ritonavir","intervention_type":"Drug"},{"arm_group_label":"Group 5","intervention_description":"8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H","intervention_name":"BMS-663068 with or without ritonavir","intervention_type":"Drug"},{"arm_group_label":"Group 3","intervention_description":"8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H","intervention_name":"BMS-663068 with or without ritonavir","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["HIV, HIV attachment inhibitor, attachment inhibitor"],"last_follow_up_date":"06/25/2010 00:00:00","links":[],"locations":[{"City":"Berlin","Latitude":"52.5411171","CountryDisplay":"Germany","Longitude":"13.3509304","Name":"GSK Investigational Site","StateDisplay":"Berlin","PostalCode":"13353","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"10/01/2018 22:44:26","number_of_arms":"5","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Randomized, Open label, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068 in HIV-1 Infected Subjects","org_study_id":"206267","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - 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