{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/204861","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":"NCT02831673","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":"true","masked_subject":"true","masking_description":"","no_masking":"false"},"PatientLevelData":"false","SharingIpd":"None","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"DTG + 3TC (50 mg+300 mg)","arm_group_description":"Eligible subjects will receive one 50 mg tablet of DTG plus one\n            overencapsulated 300 mg 3TC tablet orally once daily upto 96 weeks; thereafter will\n            receive DTG plus 3TC tablet upto Week 148 and will continue to receive this schedule\n            until (i) DTG and 3TC are both locally approved for use as part of a dual regimen, and\n            the single entities of DTG and 3TC are available to patients (e.g. through public health\n            services), or (ii) the DTG/3TC FDC tablet, if required by local regulations, is\n            available, , or (iii) the subject no longer derives clinical benefit, or (iv) the\n            subject meets a protocol defined reason for discontinuation, or (v) development of the\n            DTG plus 3TC dual regimen is terminated.","arm_type":"Experimental"},{"arm_group_label":"DTG + TDF/FTC FDC (50 mg+300/200 mg)","arm_group_description":"Eligible subjects will receive one 50 mg tablet of DTG plus one\n            overencapsulated TDF/ FTC FDC (300/200 mg) tablet orally once daily upto 96 weeks;\n            thereafter will receive DTG plus TDF/FTC FDC tablets upto Week 148 (open-label\n            randomised phase).","arm_type":"Active Comparator"}],"assignment":"Parallel Assignment","brief_summary":"This study will compare safety, efficacy, and tolerability of a two drug regimen\n          of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two\n          nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed\n          dose combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1\n          infected adult subjects that have not previously received antiretroviral therapy. The\n          study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC\n          regimen to that of DTG plus TDF/FTC FDC and will characterise the long term antiviral\n          activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700\n          subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will\n          be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening\n          CD4+ (cluster of differentiation 4) cell count.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"An efficacy, safety, and tolerability study comparing dolutegravir plus\n        lamivudine with dolutegravir plus tenofovir/emtricitabine in treatment naïve HIV infected\n        subjects (Gemini 1)","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:24:40","criteria":"Inclusion Criteria:\n\n            - Must be an HIV 1 infected adult >=18 years of age (or older, if required by local\n            regulations) at the time of signing the informed consent\n            - An eligible female subject should not be pregnant (as confirmed by a negative serum\n            human chorionic gonadotrophin (hCG) test at Screening and negative urine test at\n            Baseline), not lactating, and at least one of the following conditions applies\n            • Non reproductive premenopausal women are those that have undergone documented tubal\n            ligation or documented hysteroscopic tubal occlusion procedure with follow up\n            confirmation of bilateral tubal occlusion or documented bilateral oophorectomy or\n            hysterectomy\n            • Non reproductive premenopausal women are those with 12 months of spontaneous\n            amenorrhea and >=45 years of age\n            • Women with reproductive potential agree to follow one of the protocol-defined methods\n            for avoiding pregnancy\n            - Should have screening plasma HIV 1 RNA levels of 1000 c/mL to <=100,000 c/mL. If an\n            independent review of accumulated data from other clinical trials investigating the DTG\n            plus 3TC dual regimen is supportive of the DTG plus 3TC treatment regimen, enrolment\n            will be opened to subjects with Screening plasma HIV 1 RNA of 1000 c/mL to <=500,000\n            c/mL\n            - Subject should be antiretroviral naïve (defined as <=10 days of prior therapy with\n            any antiretroviral agent following a diagnosis of HIV 1 infection). Subjects who\n            received HIV post exposure prophylaxis (PEP) or pre exposure prophylaxis (PrEP) in the\n            past are allowed as long as the last PEP/PrEP dose was >1 year from HIV diagnosis or\n            there is documented HIV seronegativity between the last prophylactic dose and the date\n            of HIV diagnosis\n            - Subject or the subject’s legal representative capable of giving signed informed\n            consent which includes compliance with the requirements and restrictions listed in the\n            consent form and the protocol\n            - Subjects enrolled in France: a subject will be eligible for inclusion in this study\n            only if either affiliated to or a beneficiary of a social security category\n\n            Exclusion Criteria\n            - Women who are breastfeeding or plan to become pregnant or breastfeed during the study\n            - Any evidence of an active centers for disease control and prevention (CDC) Stage 3\n            disease (CDC, 2014), except cutaneous Kaposi’s sarcoma not requiring systemic therapy\n            and historical or current CD4 cell counts less than 200 cells/mm^3\n            - Subjects with severe hepatic impairment (Class C) as determined by Child Pugh\n            classification\n            - Unstable liver disease (as defined by the presence of ascites, encephalopathy,\n            coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice),\n            cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or\n            asymptomatic gallstones\n            - Evidence of hepatitis B virus (HBV) infection or HBV surface antibody (anti-HBs or\n            HBsAb) based on:\n            Subjects positive for HBV surface antigen (HBsAg) at screening will be excluded\n            Subjects negative for HBV core antibody (anti HBs) but positive for anti HBc (negative\n            HBsAg status) and positive for HBV deoxyribose nucleic acid (DNA) will be excluded;\n            however, subjects positive for anti HBc (negative HBsAg status) and positive for anti\n            HBs (past and/or current evidence) are immune to HBV and will not be excluded\n            - Anticipated need for any hepatitis B virus (HCV) therapy during the first 48 weeks of\n            the study and for HCV therapy based on interferon or any drugs that have a potential for\n            adverse drug:drug interactions with study treatment throughout the entire study period\n            - Untreated syphilis infection positive RPR at Screening without clear documentation of\n            treatment. Subjects who are at least 14 days post completed treatment are eligible\n            - History or presence of allergy or intolerance to the study drugs or their components\n            or drugs of their class\n            - Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or\n            resected, non invasive cutaneous squamous cell carcinoma, or cervical, anal or penile\n            intraepithelial neoplasia; other localised malignancies require agreement between the\n            investigator and the Study Medical Monitor for inclusion of the subject\n            - Subjects who in the Investigator’s judgment, poses a significant suicidality risk.\n            Recent history of suicidal behaviour and/or suicidal ideation may be considered as\n            evidence of serious suicide risk\n            - Treatment with an HIV 1 immunotherapeutic vaccine within 90 days of Screening\n            - Treatment with any of the following agents within 28 days of Screening:\n            • Radiation therapy,\n            • Cytotoxic chemotherapeutic agents,\n            • Any systemic immune suppressant\n            - Treatment with any agent, except recognised ART as allowed above, with documented\n            activity against HIV 1 in vitro within 28 days of first dose of study treatment\n            - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half\n            lives of the test agent, or twice the duration of the biological effect of the test\n            agent, whichever is longer, prior to the first dose of study treatment\n            - Subjects enrolled in France: the subject has participated in any study using an\n            investigational drug during the previous 60 days or 5 half lives, or twice the duration\n            of the biological effect of the experimental drug or vaccine, whichever is longer, prior\n            to screening for the study or the subject will participate simultaneously in another\n            clinical study\n            - Any evidence of pre existing viral resistance based on the presence of any major\n            resistance associated mutation in the Screening result or, if known, in any historical\n            resistance test result\n            - Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during\n            the Screening period to verify a result\n            - Any acute laboratory abnormality at Screening, which, in the opinion of the\n            Investigator, would preclude the subject’s participation in the study of an\n            investigational compound\n            - Alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN) or ALT\n            >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin)\n            - Creatinine clearance of <50 mL/min per 1.73 m^2 via the chronic kidney disease\n            epidemiology collaboration (CKD EPI) method","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":"719","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"c1edddbe-2c60-5a9a-881b-a4dbd275df7e","internal":{"content":null,"contentDigest":"21a8393d5bc367226f66f9f467ded2a1","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n\n            - Must be an HIV 1 infected adult >=18 years of age (or older, if required by local\n            regulations) at the time of signing the informed consent\n            - An eligible female subject should not be pregnant (as confirmed by a negative serum\n            human chorionic gonadotrophin (hCG) test at Screening and negative urine test at\n            Baseline), not lactating, and at least one of the following conditions applies\n            • Non reproductive premenopausal women are those that have undergone documented tubal\n            ligation or documented hysteroscopic tubal occlusion procedure with follow up\n            confirmation of bilateral tubal occlusion or documented bilateral oophorectomy or\n            hysterectomy\n            • Non reproductive premenopausal women are those with 12 months of spontaneous\n            amenorrhea and >=45 years of age\n            • Women with reproductive potential agree to follow one of the protocol-defined methods\n            for avoiding pregnancy\n            - Should have screening plasma HIV 1 RNA levels of 1000 c/mL to <=100,000 c/mL. If an\n            independent review of accumulated data from other clinical trials investigating the DTG\n            plus 3TC dual regimen is supportive of the DTG plus 3TC treatment regimen, enrolment\n            will be opened to subjects with Screening plasma HIV 1 RNA of 1000 c/mL to <=500,000\n            c/mL\n            - Subject should be antiretroviral naïve (defined as <=10 days of prior therapy with\n            any antiretroviral agent following a diagnosis of HIV 1 infection). Subjects who\n            received HIV post exposure prophylaxis (PEP) or pre exposure prophylaxis (PrEP) in the\n            past are allowed as long as the last PEP/PrEP dose was >1 year from HIV diagnosis or\n            there is documented HIV seronegativity between the last prophylactic dose and the date\n            of HIV diagnosis\n            - Subject or the subject’s legal representative capable of giving signed informed\n            consent which includes compliance with the requirements and restrictions listed in the\n            consent form and the protocol\n            - Subjects enrolled in France: a subject will be eligible for inclusion in this study\n            only if either affiliated to or a beneficiary of a social security category\n\n            Exclusion Criteria\n            - Women who are breastfeeding or plan to become pregnant or breastfeed during the study\n            - Any evidence of an active centers for disease control and prevention (CDC) Stage 3\n            disease (CDC, 2014), except cutaneous Kaposi’s sarcoma not requiring systemic therapy\n            and historical or current CD4 cell counts less than 200 cells/mm^3\n            - Subjects with severe hepatic impairment (Class C) as determined by Child Pugh\n            classification\n            - Unstable liver disease (as defined by the presence of ascites, encephalopathy,\n            coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice),\n            cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or\n            asymptomatic gallstones\n            - Evidence of hepatitis B virus (HBV) infection or HBV surface antibody (anti-HBs or\n            HBsAb) based on:\n            Subjects positive for HBV surface antigen (HBsAg) at screening will be excluded\n            Subjects negative for HBV core antibody (anti HBs) but positive for anti HBc (negative\n            HBsAg status) and positive for HBV deoxyribose nucleic acid (DNA) will be excluded;\n            however, subjects positive for anti HBc (negative HBsAg status) and positive for anti\n            HBs (past and/or current evidence) are immune to HBV and will not be excluded\n            - Anticipated need for any hepatitis B virus (HCV) therapy during the first 48 weeks of\n            the study and for HCV therapy based on interferon or any drugs that have a potential for\n            adverse drug:drug interactions with study treatment throughout the entire study period\n            - Untreated syphilis infection positive RPR at Screening without clear documentation of\n            treatment. Subjects who are at least 14 days post completed treatment are eligible\n            - History or presence of allergy or intolerance to the study drugs or their components\n            or drugs of their class\n            - Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or\n            resected, non invasive cutaneous squamous cell carcinoma, or cervical, anal or penile\n            intraepithelial neoplasia; other localised malignancies require agreement between the\n            investigator and the Study Medical Monitor for inclusion of the subject\n            - Subjects who in the Investigator’s judgment, poses a significant suicidality risk.\n            Recent history of suicidal behaviour and/or suicidal ideation may be considered as\n            evidence of serious suicide risk\n            - Treatment with an HIV 1 immunotherapeutic vaccine within 90 days of Screening\n            - Treatment with any of the following agents within 28 days of Screening:\n            • Radiation therapy,\n            • Cytotoxic chemotherapeutic agents,\n            • Any systemic immune suppressant\n            - Treatment with any agent, except recognised ART as allowed above, with documented\n            activity against HIV 1 in vitro within 28 days of first dose of study treatment\n            - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half\n            lives of the test agent, or twice the duration of the biological effect of the test\n            agent, whichever is longer, prior to the first dose of study treatment\n            - Subjects enrolled in France: the subject has participated in any study using an\n            investigational drug during the previous 60 days or 5 half lives, or twice the duration\n            of the biological effect of the experimental drug or vaccine, whichever is longer, prior\n            to screening for the study or the subject will participate simultaneously in another\n            clinical study\n            - Any evidence of pre existing viral resistance based on the presence of any major\n            resistance associated mutation in the Screening result or, if known, in any historical\n            resistance test result\n            - Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during\n            the Screening period to verify a result\n            - Any acute laboratory abnormality at Screening, which, in the opinion of the\n            Investigator, would preclude the subject’s participation in the study of an\n            investigational compound\n            - Alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN) or ALT\n            >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin)\n            - Creatinine clearance of <50 mL/min per 1.73 m^2 via the chronic kidney disease\n            epidemiology collaboration (CKD EPI) method","interventions":[{"arm_group_label":"DTG + TDF/FTC FDC (50 mg+300/200 mg)","intervention_description":"DTG is available as 50 mg white, round, biconvex, film coated tablet debossed\n            on one side with ‘SV 572’ and on the other side with ‘50’. The tablets are packaged into\n            high density polyethylene (HDPE) bottles with induction seals and child resistant\n            closures. Each 45 ml bottle contains 30 tablets and a desiccant. DTG 50 mg tablet will\n            be orally administered once daily with or without food upto 148 weeks.","intervention_name":"Dolutegravir (DTG)","intervention_type":"Drug"},{"arm_group_label":"DTG + 3TC (50 mg+300 mg)","intervention_description":"DTG is available as 50 mg white, round, biconvex, film coated tablet debossed\n            on one side with ‘SV 572’ and on the other side with ‘50’. The tablets are packaged into\n            high density polyethylene (HDPE) bottles with induction seals and child resistant\n            closures. Each 45 ml bottle contains 30 tablets and a desiccant. DTG 50 mg tablet will\n            be orally administered once daily with or without food upto 148 weeks.","intervention_name":"Dolutegravir (DTG)","intervention_type":"Drug"},{"arm_group_label":"DTG + 3TC (50 mg+300 mg)","intervention_description":"Lamivudine is available as swedish orange, ‘AA’ sized elongated double blind\n            HPMC capsules containing 300 mg lamivudine to visually match overencapsulated TDF/FTC\n            FDC tablet. The capsules are packaged into HDPE bottles with induction seals and child\n            resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant.\n            Overencapsulated 3TC 300 mg tablet will be orally administered once daily with or\n            without food upto 96 weeks. From Week 96 to Week 148, lamivudine will be dispensed as\n            300 mg white, diamond shaped, scored, film coated tablets debossed with ‘GX CJ7’ on both\n            sides, packed in over labelled HDPE bottles with child-resistant closures each\n            containing 30 tablets.","intervention_name":"Lamivudine (3TC)","intervention_type":"Drug"},{"arm_group_label":"DTG + TDF/FTC FDC (50 mg+300/200 mg)","intervention_description":"Tenofovir disoproxil fumarate and Emtricitabine are available as swedish\n            orange, ‘AA’ sized elongated double blind HPMC capsules containing 300 mg TDF and 200 mg\n            FTC to visually match overencapsulated 3TC tablet. The capsules are packaged into HDPE\n            bottles with induction seals and child resistant closures. Each 150 mL bottle contains\n            30 capsules and a desiccant. Overencapsulated tenofovir disoproxil\n            fumarate/emtricitabine tablet will be orally administered once daily with or without\n            food upto 96 weeks. From Week 96 to Week 148, tenofovir disoproxil\n            fumarate/emtricitabine will be dispensed as 300/200 mg white, blue, capsule shaped, film\n            coated tablets debossed with ‘GILEAD’ on one side and ‘701’ on another side, packed in\n            overlabelled HDPE bottles with polypropylene childresistant closures each containing 30\n            tablets and a desiccant.","intervention_name":"Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["safety","treatment naïve","HIV 1","dolutegravir plus lamivudine","non inferiority","tolerability","dolutegravir plus tenofovir/emtricitabine","efficacy"],"last_follow_up_date":"03/03/2024 00:00:00","links":[],"locations":[{"City":"Alicante","Latitude":"38.3616509","CountryDisplay":"Spain","Longitude":"-0.489172","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"03010","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Allentown","Latitude":"40.6073818","CountryDisplay":"United States","Longitude":"-75.4781662","Name":"GSK Investigational Site","StateDisplay":"Pennsylvania","PostalCode":"18102","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Antwerpen","Latitude":"51.2198771","CountryDisplay":"Belgium","Longitude":"4.4011356","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"2000","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Badalona","Latitude":"41.474766","CountryDisplay":"Spain","Longitude":"2.2285864","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"08916","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Bellaire","Latitude":"29.7057858","CountryDisplay":"United States","Longitude":"-95.4588299","Name":"GSK Investigational Site","StateDisplay":"Texas","PostalCode":"77401","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Berkley","Latitude":"42.5007019","CountryDisplay":"United States","Longitude":"-83.1916937","Name":"GSK Investigational Site","StateDisplay":"Michigan","PostalCode":"48072","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Berlin","Latitude":"52.5517268","CountryDisplay":"Germany","Longitude":"13.4123013","Name":"GSK Investigational Site","StateDisplay":"Berlin","PostalCode":"10439","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Bologna","Latitude":"44.4993258","CountryDisplay":"Italy","Longitude":"11.3985651","Name":"GSK Investigational Site","StateDisplay":"Emilia-Romagna","PostalCode":"40138","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Bonn","Latitude":"50.6980735","CountryDisplay":"Germany","Longitude":"7.0871788","Name":"GSK Investigational Site","StateDisplay":"Nordrhein-Westfalen","PostalCode":"53127","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Brescia","Latitude":"45.5428702","CountryDisplay":"Italy","Longitude":"10.2534354","Name":"GSK Investigational Site","StateDisplay":"Lombardia","PostalCode":"25123","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Brussels","Latitude":"50.8427501","CountryDisplay":"Belgium","Longitude":"4.3515499","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"1000","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Brussels","Latitude":"50.8238652","CountryDisplay":"Belgium","Longitude":"4.2986584","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"1070","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Bruxelles","Latitude":"50.8503463","CountryDisplay":"Belgium","Longitude":"4.3517211","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"1200","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Buenos Aires","Latitude":"-34.6213576","CountryDisplay":"Argentina","Longitude":"-58.3773266","Name":"GSK Investigational Site","StateDisplay":"Buenos Aires","PostalCode":"1141","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Buenos Aires","Latitude":"-34.6036844","CountryDisplay":"Argentina","Longitude":"-58.3815591","Name":"GSK Investigational Site","StateDisplay":"Buenos Aires","PostalCode":"1202","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Busan","Latitude":"35.1795543","CountryDisplay":"South Korea","Longitude":"129.0756416","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"49241","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Busto Arsizio (VA)","Latitude":"45.611892","CountryDisplay":"Italy","Longitude":"8.8531265","Name":"GSK Investigational Site","StateDisplay":"Lombardia","PostalCode":"21052","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Chapel Hill","Latitude":"35.9131996","CountryDisplay":"United States","Longitude":"-79.0558445","Name":"GSK Investigational Site","StateDisplay":"North Carolina","PostalCode":"27599-7064","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Ciudad Autonoma de Buenos Aires","Latitude":"-34.6036844","CountryDisplay":"Argentina","Longitude":"-58.3815591","Name":"GSK Investigational Site","StateDisplay":"Buenos Aires","PostalCode":"C1181ACH","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Ciudad Autónoma de Buenos 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Complete"},{"City":"Valencia","Latitude":"39.4520748","CountryDisplay":"Spain","Longitude":"-0.4101619","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"46014","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Vigo","Latitude":"42.1866194","CountryDisplay":"Spain","Longitude":"-8.6985716","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"36312","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Washington","Latitude":"38.9042365","CountryDisplay":"United States","Longitude":"-77.0521289","Name":"GSK Investigational Site","StateDisplay":"District of Columbia","PostalCode":"20037","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"West Palm Beach","Latitude":"26.7619563","CountryDisplay":"United States","Longitude":"-80.1037721","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"33407","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"},{"City":"Zapopan","Latitude":"20.7182797","CountryDisplay":"Mexico","Longitude":"-103.3659489","Name":"GSK Investigational Site","StateDisplay":"Jalisco","PostalCode":"45170","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"06/19/2024 16:36:23","number_of_arms":"2","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"A Phase III, randomised, double blind, multicentre, Parallel group, non\n        inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus\n        lamivudine compared to dolutegravir plus tenofovir/emtricitabine in human immunodeficiency\n        virus 1 infected treatment naïve adults","org_study_id":"204861","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Active, not recruiting - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":true,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 3","primary_compl_date":"03/29/2018 00:00:00","primary_outcomes":[{"outcome_description":"The proportion of responders (HIV-1 RNA <50 copies/mL) among randomized\n            subjects who received at least one dose of study medication (ITT-E population) will be\n            assessed at Week 48 according to the FDA's Snapshot algorithm.","outcome_measure":"Percentage of subjects with plasma HIV 1 RNA <50 copies/milliliter at\n          Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"product_name":"GSK2326285;dolutegravir;dolutegravir/lamivudine;emtricitabine;lamivudine;tenofovir\n        disoproxil fumarate","product_name_OneLinkTx":"","secondary_ids":[{"id":"2015-004418-95","id_type":"EudraCT Number","id_domain":""},{"id":"2023-503951-81-00","id_type":"Registry Identifier","id_domain":"EU CT number"}],"secondary_outcomes":[{"outcome_description":"The proportion of responders (HIV-1 RNA <50 copies/mL) among randomized\n            subjects in the ITT-E population will be assessed at Weeks 24, 96 and 144 according to\n            the FDA's Snapshot algorithm","outcome_measure":"Percentage of subjects with plasma HIV 1 RNA <50 copies/milliliter at\n          Weeks 24, 96, and 144","outcome_time_frame":"Week 24, 96, and 144","outcome_safety_issue":null},{"outcome_description":"Time to HIV-1 RNA <50 copies/mL","outcome_measure":"Time to viral suppression (HIV 1 RNA <50 copies/milliliter) over time","outcome_time_frame":"Up to Week 144","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for assessment of lymphocytes by flow cytometry","outcome_measure":"Absolute values in CD4+ cell counts at Weeks 24, 48, 96 and 144","outcome_time_frame":"Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for assessment of lymphocytes by flow cytometry","outcome_measure":"Changes from Baseline in CD4+ cell counts at Weeks 24, 48, 96 and 144","outcome_time_frame":"Baseline (Day 1), Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"Antiviral and immunological activity evaluated by incidence of disease\n            progression (HIV-associated conditions, Acquired immune deficiency syndrome and death)\n            over time","outcome_measure":"Number of subjects with disease progression (HIV associated conditions,\n          acquired immunodeficiency syndrome, and death) over time","outcome_time_frame":"Up to Week 144","outcome_safety_issue":null},{"outcome_description":"Viral genotype for both Baseline samples and from samples collected at the time\n            of meeting a virologic withdrawal criterion may be analysed","outcome_measure":"Incidence of treatment-emergent genotypic resistance to DTG and 3TC or\n          TDF/FTC in subjects meeting confirmed virologic withdrawal criteria","outcome_time_frame":"Up to Week 148 and then every 12 week post Week 148 (assessed Upto a\n          maximum of 3.5 years)","outcome_safety_issue":null},{"outcome_description":"Serious adverse event (SAE) is any untoward medical occurrence that, at any\n            dose can result in death, or is life threatening or requires hospitalisation or\n            prolongation of existing hospitalization or results in disability/incapacity or is a\n            congenital anomaly/birth defect or is associated with liver injury and impaired liver\n            function. An adverse event (AE) can be any unfavourable and unintended sign (including\n            an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally\n            associated with the use of a medicinal product.","outcome_measure":"Number of subjects with adverse events and serious adverse events over time","outcome_time_frame":"Up to end of study (Approximately 7 years)","outcome_safety_issue":null},{"outcome_description":"Viral phenotype for both Baseline samples and from samples collected at the\n            time of meeting a virologic withdrawal criterion may be analysed","outcome_measure":"Incidence of treatment-emergent phenotypic resistance to DTG and 3TC or\n          TDF/FTC in subjects meeting confirmed virologic withdrawal criteria","outcome_time_frame":"Up to end of study (Approximately 7 years)","outcome_safety_issue":null},{"outcome_description":"Safety and tolerability of DTG + 3TC will be compared to DTG + TDF/FTC over\n            time. An AE is any untoward medical occurrence in a patient or clinical investigation\n            subject, temporally associated with the use of a medicinal product, whether or not\n            considered related to the medicinal product.","outcome_measure":"Number of subjects with adverse events (AEs), severity of AEs and treatment\n          discontinuations due to AEs over time","outcome_time_frame":"Up to end of study (Approximately 7 years)Baseline and up to Week 144","outcome_safety_issue":null},{"outcome_description":"Safety will be assessed in terms of biomarkers. Blood and urine samples will be\n            collected for renal biomarker assessments.","outcome_measure":"Change from Baseline in renal biomarkers","outcome_time_frame":"Baseline (Day 1), Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"Safety will be assessed in terms of biomarkers. Blood samples will be collected\n            for bone biomarker assessments","outcome_measure":"Change from Baseline in bone biomarkers","outcome_time_frame":"Baseline (Day 1), Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"Samples for lipid measurements will be obtained in a fasted state. Effects of\n            DTG + 3TC on fasting lipids will be compared to DTG + TDF/FTC.","outcome_measure":"Change from Baseline in fasting lipids","outcome_time_frame":"Baseline (Day 1), Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"Samples for lipid measurements will be obtained in a fasted state. Grade 2 or 3\n            low density lipoprotein cholesterol (as per Division of AIDS Table for Grading the\n            Severity of Adult and Pediatric Adverse Events).","outcome_measure":"Number of subjects with Grade 2 or greater laboratory abnormalities in\n          fasting low density lipoprotein cholesterol over time","outcome_time_frame":"Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"Impact of age, gender, Baseline CD4+ cell count on antiviral activity of DTG +\n            3TC compared to DTG + TDF/FTC","outcome_measure":"Percentage of subjects with plasma HIV 1 RNA <50 c/mL by subgroups based\n          on age, gender, Baseline CD4+ cell count","outcome_time_frame":"Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"Impact of age, gender, Baseline CD4+ cell count on immunological activity of\n            DTG + 3TC compared to DTG + TDF/FTC","outcome_measure":"Change from Baseline in CD4+ cell count by patient subgroups based on age,\n          gender, Baseline CD4+ cell count","outcome_time_frame":"Baseline (Day 1), Weeks 24, 48, 96 and 144","outcome_safety_issue":null},{"outcome_description":"The European quality of life 5 dimensions 5 levels (EQ-5D-5L), is a\n            self-reported scale that provides a profile of patient function (including mobility,\n            self care, usual activities, pain/discomfort, and anxiety/depression) and a global\n            health state rating.","outcome_measure":"Change from Baseline in health related quality of life","outcome_time_frame":"Baseline (Day 1), Weeks 4, 24, 48, 96 and 144","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["PPD","GlaxoSmithKline"]},"start_date":"07/21/2016 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[{"citation":"Cahn P, Sierra Madero JS, Arrivas JR, et al.Dolutegravir plus lamivudine versus\n          dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive\n          adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre,\n          double-blind, randomised, non-inferiority, phase 3 trials.Lancet.2019;393(10167):143-155","is_results_ref":"","pubmed_id":""}],"is_section_801":true}},"pageContext":{"studyId":"204861"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}