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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.
"}},"ctGov":{"childMarkdownRemark":{"html":"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.
"}},"eudraCT":{"childMarkdownRemark":{"html":"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.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT01231516","ctis_id":"","HasResults":"true","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"true","masked_caregiver":"true","masked_investigator":"true","masked_subject":"true","masking_description":"","no_masking":"false"},"PatientLevelData":"true","SharingIpd":"None","acronym":"SAILING","allocation":"Randomized","arm_groups":[{"arm_group_label":"GSK1349572 + Raltegravir Placebo","arm_group_description":"Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.","arm_type":"Experimental"},{"arm_group_label":"Raltegravir + GSK1349572 Placebo","arm_group_description":"Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.","arm_type":"Active Comparator"}],"assignment":"Parallel Assignment","brief_summary":"ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"A Study of GSK1349572 versus Raltegravir (RAL) with Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:20:10","criteria":"Inclusion Criteria:\n - Antiretroviral therapy (ART)-experienced, Human Immunodeficiency Virus (HIV) -1 infected adults at least 18 years of age.\n - Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol).\n - HIV-1 infection as documented by HIV-1 RNA >400 copies/mL (c/mL) at Screening and with at least one consecutive HIV-1 RNA >400 c/mL within the four months prior to Screening (unless the Screening HIV-1 RNA is > 1000 c/mL where no additional plasma HIV-1 RNA assessment is needed). \n - Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents. For subjects off ART for at least one month, if Screening resistance results provide a fully active agent and do not show two class resistance then historical resistance results from the subject's most recent resistance testing may be used, following consultation with the study virologist and /or medical monitor.\n - Integrase inhibitor (INI)-naïve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572).\n - Able to provide written informed consent prior to Screening.\n - French subjects: In France, subjects will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.\n\nExclusion Criteria:\n - Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.\n - Subject-virus does not yield results using genotype/phenotype/tropism at Screening (assay data is essential for eligibility determination).\n - Women who are breastfeeding.\n - Any evidence of an active AIDS-defining condition (except cutaneous Kaposi’s sarcoma not requiring systemic therapy or CD4+ <200c/mm3).\n - Subjects with moderate to severe hepatic impairment as defined by Child-Pugh classification. \n - Recent history (less than or equal to 3 months) of upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.\n - Anticipated need for hepatitis C therapy during the study.\n - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. \n - History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and study medical monitor for inclusion of the subject.\n - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to Screening.\n - Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulator.\n - Treatment with any agent, other than licensed ART, which has documented activity against HIV-1 in vitro within 28 days of first dose of investigational product.\n - Exposure to an experimental drug and/or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the experimental test agent - whichever is longer, prior to the first dose of IP.\n - French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational drug and/or vaccine within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine – whichever is longer - prior to screening for the study or the subject plans to participate simultaneously in another clinical study.\n - Any acute or verified Grade 4 laboratory abnormality. \n - Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).\n - ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with >35% direct bilirubin).","detailed_description":"ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. 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An additional data cut and analysis will be conducted after the last subject completes 24 weeks on therapy. \n\nSubjects randomized to GSK1349572 who successfully complete Week 48 will continue to received GSK1349572 until either it is locally available, until they no longer derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.\n\nViiV Healthcare is the sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 3","display_phase_internal":"PHASE_3","display_status":"Active, not recruiting","display_status_internal":"RECSTATUS_I_ACTIVE_NOT_REC","endpoint":"","enrollment":"724","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"7c3e924d-b4b2-577b-a0a0-80662077e9b1","internal":{"content":null,"contentDigest":"3e90e449fb2f2ce6081044b24e2e3fde","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - Antiretroviral therapy (ART)-experienced, Human Immunodeficiency Virus (HIV) -1 infected adults at least 18 years of age.\n - Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol).\n - HIV-1 infection as documented by HIV-1 RNA >400 copies/mL (c/mL) at Screening and with at least one consecutive HIV-1 RNA >400 c/mL within the four months prior to Screening (unless the Screening HIV-1 RNA is > 1000 c/mL where no additional plasma HIV-1 RNA assessment is needed). \n - Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents. For subjects off ART for at least one month, if Screening resistance results provide a fully active agent and do not show two class resistance then historical resistance results from the subject's most recent resistance testing may be used, following consultation with the study virologist and /or medical monitor.\n - Integrase inhibitor (INI)-naïve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572).\n - Able to provide written informed consent prior to Screening.\n - French subjects: In France, subjects will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.\n\nExclusion Criteria:\n - Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.\n - Subject-virus does not yield results using genotype/phenotype/tropism at Screening (assay data is essential for eligibility determination).\n - Women who are breastfeeding.\n - Any evidence of an active AIDS-defining condition (except cutaneous Kaposi’s sarcoma not requiring systemic therapy or CD4+ <200c/mm3).\n - Subjects with moderate to severe hepatic impairment as defined by Child-Pugh classification. \n - Recent history (less than or equal to 3 months) of upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.\n - Anticipated need for hepatitis C therapy during the study.\n - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. \n - History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and study medical monitor for inclusion of the subject.\n - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to Screening.\n - Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulator.\n - Treatment with any agent, other than licensed ART, which has documented activity against HIV-1 in vitro within 28 days of first dose of investigational product.\n - Exposure to an experimental drug and/or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the experimental test agent - whichever is longer, prior to the first dose of IP.\n - French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational drug and/or vaccine within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine – whichever is longer - prior to screening for the study or the subject plans to participate simultaneously in another clinical study.\n - Any acute or verified Grade 4 laboratory abnormality. \n - Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).\n - ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with >35% direct bilirubin).","interventions":[{"arm_group_label":"GSK1349572 + Raltegravir Placebo","intervention_description":"50mg once daily","intervention_name":"GSK1349572","intervention_type":"Drug"},{"arm_group_label":"Raltegravir + GSK1349572 Placebo","intervention_description":"400mg twice daily","intervention_name":"Raltegravir","intervention_type":"Drug"},{"arm_group_label":"Raltegravir + GSK1349572 Placebo","intervention_description":"Inactive placebo tablet once daily","intervention_name":"GSK1349572 Placebo","intervention_type":"Drug"},{"arm_group_label":"GSK1349572 + Raltegravir Placebo","intervention_description":"Inactive placebo tablet twice daily","intervention_name":"Raltegravir Placebo","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["ART-experienced","Integrase inhibitor","Raltegravir","GSK1349572","Integrase inhibitor naive"],"last_follow_up_date":"06/30/2019 00:00:00","links":[],"locations":[{"City":"Strasbourg cedex","Latitude":"48.575782","CountryDisplay":"France","Longitude":"7.742941","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"67091","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Miami Beach","Latitude":"25.783312","CountryDisplay":"United States","Longitude":"-80.1484407","Name":"GSK Investigational 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This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study.","outcome_measure":"Percentage of participants with HIV-1 RNA <50 copies/milliliter (c/mL) at Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"product_name":"dolutegravir;raltegravir","product_name_OneLinkTx":"","secondary_ids":[{"id":"2009-018001-51","id_type":"EudraCT Number","id_domain":""}],"secondary_outcomes":[{"outcome_description":"For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.","outcome_measure":"Number of participants (par.) with detectable virus that has genotypic or phenotypic evidence of treatment-emergent INI resistance at time of protocol defined virology failure (PDVF)","outcome_time_frame":"Baseline until PDVF up to Week 48","outcome_safety_issue":null},{"outcome_description":"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) \"snapshot\" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis.","outcome_measure":"Number of participants with plasma HIV-1 RNA <50 c/mL at Week 24","outcome_time_frame":"Week 24","outcome_safety_issue":null},{"outcome_description":"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) \"snapshot\" algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment.","outcome_measure":"Number of participants with plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48","outcome_time_frame":"Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline (BL), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40 and Week 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.","outcome_measure":"Absolute values and change from Baseline in cluster of differentiation 4+ (CD4+) cell counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48","outcome_time_frame":"Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48","outcome_safety_issue":null},{"outcome_description":"Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.","outcome_measure":"Number of participants with indicated post-Baseline HIV-associated conditions, excluding recurrences, and disease progressions","outcome_time_frame":"From Baseline (Day 1) until Week 48","outcome_safety_issue":null},{"outcome_description":"All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. .","outcome_measure":"Number of participants with the indicated post-Baseline emergent Grade 1 to 4 clinical chemistry and hematology toxicities/laboratory adverse events (AEs)","outcome_time_frame":"From Baseline until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study","outcome_safety_issue":null},{"outcome_description":"The maximal concentration (Cmax), and the minimal concentration (Cmin) were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 as well as the average C0 (C0_avg) , Cmax and Cmin were estimated and reported here.","outcome_measure":"DTG PK parameters including Cmax, Cmin, C0, and C0_avg","outcome_time_frame":"Week 4, Week 24, and Week 48","outcome_safety_issue":null},{"outcome_description":"AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48.","outcome_measure":"DTG PK parameters including AUC(0-tau)","outcome_time_frame":"Week 4, Week 24, and Week 48","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["Shionogi","GSK"]},"start_date":"10/26/2010 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[{"citation":"Cahn P, Pozniak A, Mingrone H, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. July 2013 epub ahead of print.","is_results_ref":"","pubmed_id":""}],"is_section_801":true}},"pageContext":{"studyId":"111762"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}