{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/206739","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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with HIV-1 clade B\nvi) In Part C, all subjects are infected with HIV-1 clade C\n\nExclusion Criteria:\n- History of genotypic and/or phenotypic drug resistance testing showing resistance to protease inhibitors\n- Any significant acute or chronic medical illness which is not stable or is not controlled with medication or not consistent with HIV-1 infection\n- Receive antiretroviral treatment within 12 weeks prior to screening\n- Currently co-infected with hepatitis C or hepatitis B\n- Previously received an HIV maturation inhibitor or HIV protease inhibitor\n- Current or recent (within 3 months of study drug administration) gastrointestinal disease\n- Any major surgery within 4 weeks of study drug administration\n- Acute diarrhea lasting ≥1 day, within 3 weeks prior to randomization\n- Subjects with history of Gilbert's syndrome\n- Subjects previously received an HIV maturation inhibitor or HIV protease inhibitor\n- A personal history of clinically relevant cardiac disease, symptomatic 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A personal or family history of long QT syndrome\n- Patients who are unwilling to practice adequate infection protection during and after study participation to minimize potential for spread of HIV infection,\nincluding HIV which may have developed resistance to HIV maturation inhibitor and/or ATV \n- Any gastrointestinal surgery that could impact upon the absorption of study drug\n- Smoking >10 cigarettes per day\n- PR ≥210 msec; QRS ≥120 msec; QT ≥500 msec; and QTcF ≥470 msec for women and ≥450 msec for men\n- Evidence of second or third degree heart block prior to study drug\n- Absolute Neutrophil Count <(ANC) 0.7 x lower limit of normal (LLN)\n- Hemoglobin <0.8 x LLN\n-  Alanine aminotransferase (ALT) >1.25 x upper limit of normal (ULN)\n-  Aspartate aminotransferase (AST) >1.25 x ULN\n-  Total Bilirubin >1.25 x ULN\n- Creatinine clearance <60 mL/mim\n- Positive urine screen for drugs of abuse without a valid prescription (subjects positive for cannabinoids and/or amphetamines will be included)\n- Positive blood screen for hepatitis C virus (HCV) RNA, hepatitis B surface antigen (consistent with active or chronic hepatitis B), or HIV-2 antibody\n- History of any significant drug allergy","interventions":[{"arm_group_label":"Part B-Group 12: BMS-955176 (80 mg) + Atazanavir","intervention_description":"BMS-955176","intervention_name":"BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo","intervention_description":"BMS-955176","intervention_name":"BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part A-Group 3: BMS-955176 (20 mg) or Placebo","intervention_description":"BMS-955176","intervention_name":"BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part A-Group 10: BMS-955176 (120 mg) or Placebo","intervention_description":"BMS-955176","intervention_name":"BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part B-Group 6: BMS-955176 + Atazanavir + 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Placebo","intervention_description":"Placebo matching with BMS-955176","intervention_name":"Placebo matching with BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part A-Group 1: BMS-955176 (5 mg) or Placebo","intervention_description":"Placebo matching with BMS-955176","intervention_name":"Placebo matching with BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part C-Group 8: BMS-955176 (40 mg) or Placebo","intervention_description":"Placebo matching with BMS-955176","intervention_name":"Placebo matching with BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part A-Group 2: BMS-955176 (10 mg) or Placebo","intervention_description":"Placebo matching with BMS-955176","intervention_name":"Placebo matching with BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Part C-Group 13: BMS-955176 (120 mg) or Placebo","intervention_description":"Placebo matching with BMS-955176","intervention_name":"Placebo matching with 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12:11:07","number_of_arms":"13","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 with Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects","org_study_id":"206739","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"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 1/Phase 2","primary_compl_date":"11/29/2014 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Change in plasma HIV-1 RNA levels from baseline (Day 1-predose) on Day 11 with monotherapy","outcome_time_frame":"Baseline (Day 1-predose) and Day 11 after the final dose with BMS-955176","outcome_safety_issue":null}],"product_name":"BMS-955176;GSK2326285;atazanavir;emtricitabine;ritonavir;tenofovir disoproxil fumarate","product_name_OneLinkTx":"","secondary_ids":[{"id":"2012-004124-38","id_type":"EudraCT Number","id_domain":""},{"id":"AI468-002","id_type":"Other Identifier","id_domain":"Bristol-Myers Squibb"}],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Safety based on frequency of Adverse events (AEs), serious AEs, discontinuations due to AEs, findings of marked abnormalities in vital signs, clinical laboratory tests, ECG readings and physical examinations","outcome_time_frame":"Up to day 24 (Groups 1-4, 8-10 and 13), up to day 28 (optional group 11) and up to day 42 (Part 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