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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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"}},"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":"NCT02227238","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":"true"},"PatientLevelData":"false","SharingIpd":"None","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"DTG arm","arm_group_description":"Subjects will receive one oral tablet of 50 mg DTG once daily plus two NRTIs selected by the investigator","arm_type":"Experimental"},{"arm_group_label":"LPV/RTV arm","arm_group_description":"Subjects will receive four oral tablets of200/50 mg LPV/RTV once daily or two oral tablets of 200/50 mg LPV/RTV twice daily plus two NRTIs selected by the investigator","arm_type":"Active Comparator"}],"assignment":"Parallel Assignment","brief_summary":"For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors (NRTIs) for first-line antiretroviral therapy (ART); however, there is a need for further data on the best treatment options for people with HIV-1 who have virological failure with this first-line regimen. The number of patients failing on their first-line regimen is increasing thereby requiring a switch to second-line treatment to reduce accumulation of drug-resistance mutations, disease progression, HIV transmission, and death. WHO guidelines recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a ritonavir-boosted protease inhibitor (PI); atazanavir (ATV) plus ritonavir (RTV) or lopinavir (LPV)/RTV are the preferred boosted PI options. This study is conducted to demonstrate non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV + two NRTIs, in HIV-1 infected patients failing first line therapy. This study comprises of a Screening Phase (approximately 28 to 42 days), a Randomized Phase (Day 1 to Week 48 plus a 4-week treatment extension), and a Continuation Phase. Approximately 612 subjects will be randomized 1:1 to receive DTG 50 milligram (mg) once daily or LPV/RTV (800/200 mg once daily or 400/100 mg twice daily, in accordance with investigator decision and local label), each added to an investigator selected background regimen of two NRTIs at least one of which needs to be fully active based on viral resistance testing at Screening. Subjects randomized to receive DTG who successfully complete 52 weeks of treatment will continue to have access to DTG until it is either locally approved and commercial supplies are available to patients or the patient no longer derives clinical benefit, or the patient meets a protocol-defined reason for discontinuation.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Comparative efficacy and safety study of dolutegravir and lopinavir/ritonavir in second-line treatment","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:22:27","criteria":"Inclusion Criteria: - HIV-1 infected subjects >=18 years of age. - A female subject may be eligible to enter and participate in the study if she: is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of child-bearing potential, with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the protocol-defined methods of contraception to avoid pregnancy. - HIV-1 infection as documented by HIV-1 RNA >=400 c/mL at Screening. - Subject has been on a first-line treatment regimen consisting of an NNRTI plus two NRTIs for at least 6 months and is currently experiencing virologic failure to this first-line regimen defined as two consecutive (>=7 days apart) HIV-1 RNA results of >=400 c/mL. - Subjects must receive at least one fully active agent within the dual-NRTI background regimen for second line treatment. Fully active is defined by the Screening genotypic resistance report of the central laboratory (or a laboratory contracted by the central laboratory) showing no evidence of full or of partial resistance for a given NRTI which will be taken on study. - Subject is PI-naïve and Integrase inhibitor (INI)-naïve, defined as no prior or current exposure to any PI or INI. - Subject or the subject’s legal representative is willing and able to understand and provide signed and dated written informed consent prior to screening. Exclusion Criteria: - Women who are breastfeeding. - Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease Exceptions include cutaneous Kaposi’s sarcoma not requiring systemic therapy and historic or current CD4+ cell levels <200 cells per cubic millimeter - Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification - Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). - Anticipated need for hepatitis C virus (HCV) therapy during the Randomised Phase of the study. - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. - Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject. - Subjects who in the investigator’s judgment, poses a significant suicidality risk. Recent history of suicidal behaviour and/or suicidal ideation may be considered as evidence of serious suicide risk. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. - Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, systemically administered immunomodulators. - Treatment with any agent, other than licensed ART as allowed above with documented activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. The exception is use of entecavir, in appropriate clinical situations, for treatment of hepatitis B [e.g. prior intolerance to Tenofovir (TDF), viral resistance to lamivudine (3TC) / Emtricitabine (FTC)] after discussion and agreement between the investigator and the medical monitor. - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP. - Any evidence of primary viral resistance to PIs or INIs based on the presence of any major resistance-associated mutation. - The subject’s virus does not yield results using genotype at Screening (assay data is essential for eligibility determination). - Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result. - Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study of an investigational compound. - Alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN) or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin)","detailed_description":"","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":"627","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"b4608465-14c9-56a0-abc9-284a41282e2a","internal":{"content":null,"contentDigest":"37e0659bb215f873f9aebf4720e4e58e","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - HIV-1 infected subjects >=18 years of age. - A female subject may be eligible to enter and participate in the study if she: is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of child-bearing potential, with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the protocol-defined methods of contraception to avoid pregnancy. - HIV-1 infection as documented by HIV-1 RNA >=400 c/mL at Screening. - Subject has been on a first-line treatment regimen consisting of an NNRTI plus two NRTIs for at least 6 months and is currently experiencing virologic failure to this first-line regimen defined as two consecutive (>=7 days apart) HIV-1 RNA results of >=400 c/mL. - Subjects must receive at least one fully active agent within the dual-NRTI background regimen for second line treatment. Fully active is defined by the Screening genotypic resistance report of the central laboratory (or a laboratory contracted by the central laboratory) showing no evidence of full or of partial resistance for a given NRTI which will be taken on study. - Subject is PI-naïve and Integrase inhibitor (INI)-naïve, defined as no prior or current exposure to any PI or INI. - Subject or the subject’s legal representative is willing and able to understand and provide signed and dated written informed consent prior to screening. Exclusion Criteria: - Women who are breastfeeding. - Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease Exceptions include cutaneous Kaposi’s sarcoma not requiring systemic therapy and historic or current CD4+ cell levels <200 cells per cubic millimeter - Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification - Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). - Anticipated need for hepatitis C virus (HCV) therapy during the Randomised Phase of the study. - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. - Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject. - Subjects who in the investigator’s judgment, poses a significant suicidality risk. Recent history of suicidal behaviour and/or suicidal ideation may be considered as evidence of serious suicide risk. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. - Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, systemically administered immunomodulators. - Treatment with any agent, other than licensed ART as allowed above with documented activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. The exception is use of entecavir, in appropriate clinical situations, for treatment of hepatitis B [e.g. prior intolerance to Tenofovir (TDF), viral resistance to lamivudine (3TC) / Emtricitabine (FTC)] after discussion and agreement between the investigator and the medical monitor. - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP. - Any evidence of primary viral resistance to PIs or INIs based on the presence of any major resistance-associated mutation. - The subject’s virus does not yield results using genotype at Screening (assay data is essential for eligibility determination). - Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result. - Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study of an investigational compound. - Alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN) or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin)","interventions":[{"arm_group_label":"DTG arm","intervention_description":"DTG is supplied as 50 mg tablets","intervention_name":"DTG","intervention_type":"Drug"},{"arm_group_label":"LPV/RTV arm","intervention_description":"LPV/RTV is supplied as the LPV/RTV oral tablet, which contains 200 mg of LPV and 50 mg of RTV","intervention_name":"LPV/RTV","intervention_type":"Drug"},{"arm_group_label":"LPV/RTV arm","intervention_description":"Investigators will choose a dual NRTI background regimen for each subject . In consultation with the medical monitor, 3TC may be added as a third NRTI to a dual-NRTI background regimen in subjects with chronic HBV infection and evidence of HIV resistance to 3TC","intervention_name":"Two NRTIs","intervention_type":"Drug"},{"arm_group_label":"DTG arm","intervention_description":"Investigators will choose a dual NRTI background regimen for each subject . In consultation with the medical monitor, 3TC may be added as a third NRTI to a dual-NRTI background regimen in subjects with chronic HBV infection and evidence of HIV resistance to 3TC","intervention_name":"Two NRTIs","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["integrase inhibitor","non-inferiority","dolutegravir","lopinavir/ritonavir","second-line treatment","HIV-1","antiretroviral therapy-experienced"],"last_follow_up_date":"12/31/2021 00:00:00","links":[],"locations":[{"City":"Buenos Aires","Latitude":"-34.6036844","CountryDisplay":"Argentina","Longitude":"-58.3815591","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"C1221ADC","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"},{"City":"Medellin","Latitude":"6.244203","CountryDisplay":"Colombia","Longitude":"-75.5812119","Name":"GSK Investigational 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00:00:00","primary_outcomes":[{"outcome_description":"The proportion of responders (HIV-1 RNA <50 c/mL) among randomized subjects who receive at least one dose of study medication (ITT-E population) will be assessed at Week 48 according to the FDA’s Snapshot algorithm. Non-responders are subjects with HIV-1 RNA >=50 c/mL, without HIV RNA data at Week 48, subjects with background ART substitutions not permitted per protocol and subjects with background ART substitutions permitted per protocol after Week 4 but where their last HIV-1 RNA result prior to the date of decision to switch was >=50 c/mL.","outcome_measure":"Proportion of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/millilitre (c/mL) using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure) for the ITT-E population","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"The proportion of responders (HIV-1 RNA <50 c/mL) will be assessed at Week 24 according to the FDA’s Snapshot algorithm. Non-responders are subjects with HIV-1 RNA >=50, without HIV RNA data at Week 24, subjects with background ART substitutions not permitted per protocol and subjects with background ART substitutions permitted per protocol after Week 4 but where their last HIV-1 RNA result prior to the date of decision to switch was >=50 c/mL.","outcome_measure":"Proportion of subjects with plasma HIV-1 RNA <50 c/mL using the Snapshot algorithm","outcome_time_frame":"Week 24","outcome_safety_issue":null},{"outcome_description":"The proportion of responders (HIV-1 RNA <400 c/mL) will be assessed at Weeks 24 and 48 according to the FDA’s Snapshot algorithm. Non-responders are subjects with HIV-1 RNA >=400, without HIV RNA data at Week 24/48, subjects with background ART substitutions not permitted per protocol and subjects with background ART substitutions permitted per protocol after Week 4 but where their last HIV-1 RNA result prior to the date of decision to switch was >=50 c/mL.","outcome_measure":"Proportion of subjects with plasma HIV-1 RNA <400 c/mL using the Snapshot algorithm","outcome_time_frame":"Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Failure will be defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy)","outcome_measure":"Proportion of subjects without virologic or tolerability failure by Weeks 24 and 48","outcome_time_frame":"Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Time to HIV-1 RNA <50 c/mL","outcome_measure":"Time to viral suppression","outcome_time_frame":"Up to Week 48","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for assessment of lymphocyte subsets by flow cytometry (total lymphocyte counts, percentage, and absolute CD4+ cell count counts)","outcome_measure":"Absolute values and changes from Baseline in cluster of differentiation 4 (CD4)+ cell counts at Weeks 24 and 48","outcome_time_frame":"Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Antiviral and immunological activity evaluated by incidence of disease progression (HIV-associated conditions, Acquired immune deficiency syndrome and death) over time","outcome_measure":"Incidence of disease progression","outcome_time_frame":"Up to Week 48","outcome_safety_issue":null},{"outcome_description":"AE is Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product","outcome_measure":"Incidence and severity of Adverse Events (AEs)","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"Laboratory parameters include haematology, clinical chemistry, and urinalysis.","outcome_measure":"Incidence and severity of laboratory abnormalities","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"Samples for lipid measurements will be obtained in a fasted state","outcome_measure":"Change from Baseline in fasting Low density lipoprotein (LDL)cholesterol","outcome_time_frame":"Baseline, Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Samples for lipid measurements will be obtained in a fasted state","outcome_measure":"Change from Baseline in fasting Total cholesterol / High density lipoprotein ratio","outcome_time_frame":"Baseline, Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Samples for lipid measurements will be obtained in a fasted state","outcome_measure":"Incidence of maximum post-Baseline emergent Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol","outcome_time_frame":"Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Grade 2, 3 or 4 diarrhoea (as per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events) considered by the investigator to be related or possibly related to study drug","outcome_measure":"Incidence of maximum post-Baseline emergent Grade 2 or greater drug-related diarrhoea","outcome_time_frame":"Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Proportion of subjects who discontinue treatment due to AEs will be determined throughout the study","outcome_measure":"Proportion of subjects who discontinue treatment due to AEs","outcome_time_frame":"up to Week 52","outcome_safety_issue":null},{"outcome_description":"GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS will be administered as a paper questionnaire.","outcome_measure":"Change from Baseline, using the Gastrointestinal Symptom Rating Scale (GSRS)","outcome_time_frame":"Week 4, Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"HIVTSQ is self-reported scale that measure overall satisfaction with treatment and by specific domains, e.g. convenience, flexibility. The HIVTSQ will be administered as a paper questionnaire.","outcome_measure":"Change from Baseline in treatment satisfaction, using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ)","outcome_time_frame":"Week 4, Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"It is self-reported scale with eight-items. Scores of 8 indicate high or near perfect adherence, and scores of 6 or less indicate poor or inadequate adherence on the MMAS-8 scale.","outcome_measure":"Change from Baseline in adherence with treatment, using the Morisky Medication Adherence eight item scale (MMAS-8), at Weeks 4, 24 and 48","outcome_time_frame":"Week 4, Week 24, Week 48","outcome_safety_issue":null},{"outcome_description":"Viral genotype and phenotype for both Baseline samples and from samples collected at the time of meeting a virologic withdrawal criterion may be analysed","outcome_measure":"Incidence of treatment-emergent genotypic and phenotypic resistance to DTG, LPV/RTV and other on-study ART in subjects meeting confirmed virologic withdrawal criteria","outcome_time_frame":"Up to Week 48","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GlaxoSmithKline"]},"start_date":"12/11/2014 00:00:00","study_type":"Interventional","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"200304"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}