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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.
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Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.","IpdDescription":"IPD for this study will be made available via the Clinical Study Data Request site.","IpdInfoTypeAnalyticCode":"No","IpdInfoTypeIcf":"Yes","IpdInfoTypeCsr":"Yes","IpdInfoTypeProtocol":"Yes","IpdInfoTypeSap":"Yes","IpdTimeFrame":"IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.","IpdUrl":"http://clinicalstudydatarequest.com","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"Yes","acronym":"","allocation":"","arm_groups":[{"arm_group_label":"Subjects receiving 2DR treatment","arm_group_description":"Data will be collected from HIV positive male or female adult subjects who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014.","arm_type":""}],"assignment":"","brief_summary":"Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"'COMBINE-2': Real-world evidence for effectiveness of Two Drug Regimen, Antiretroviral therapy with integrase inhibitors plus a reverse transcriptase inhibitor","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"05/20/2020 14:09:02","criteria":"Inclusion Criteria:\n - HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.\n\nExclusion Criteria:\n - No specific exclusion criteria","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Ongoing","display_status_internal":"RECSTATUS_O_ONGOING","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"No","gender_description":"","healthy_volunteers":"","id":"4f7e025c-31c1-5c6f-8bce-30a3f74f0295","internal":{"content":null,"contentDigest":"4bd49afed7d0cd4b3fa420bbd82fde89","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.\n\nExclusion Criteria:\n - No specific exclusion criteria","interventions":[{"arm_group_label":"Subjects receiving 2DR treatment","intervention_description":"DTG is a 2nd generation integrase strand transfer inhibitor. Subjects receiving DTG as a part of 2DR treatment will be included in the study.","intervention_name":"Dolutegravir (DTG)","intervention_type":"Drug"},{"arm_group_label":"Subjects receiving 2DR treatment","intervention_description":"3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.","intervention_name":"Lamivudine (3TC)","intervention_type":"Drug"},{"arm_group_label":"Subjects receiving 2DR treatment","intervention_description":"RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.","intervention_name":"Rilpivirine (RPV)","intervention_type":"Drug"},{"arm_group_label":"","intervention_description":"3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.","intervention_name":"Lamivudine (3TC)","intervention_type":"drug"},{"arm_group_label":"","intervention_description":"DTG is a 2nd generation integrase strand transfer inhibitor. Subjects receiving DTG as a part of 2DR treatment will be included in the study.","intervention_name":"Dolutegravir (DTG)","intervention_type":"drug"},{"arm_group_label":"","intervention_description":"RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.","intervention_name":"Rilpivirine (RPV)","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["2DR","HIV","Lamivudine","COMBINE-2","Dolutegravir"],"last_follow_up_date":"12/31/2021 00:00:00","links":[],"locations":[{"City":"Barcelona","Latitude":"41.4182256","CountryDisplay":"Spain","Longitude":"2.1769564","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"08041","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"05/20/2020 14:09:02","number_of_arms":"0","observational_design":{"biospecimen_description":"NA","biospecimen_retention":"None Retained","number_of_groups":"1","observational_study_design":"Cohort","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Prospective"},"official_title":"‘COMBINE-2’: Real-world evidence for effectiveness of Two Drug Regimen, Antiretroviral therapy with integrase inhibitors plus a reverse transcriptase inhibitor","org_study_id":"207859","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Recruiting - Observational","oversight_info":{"exported_from_us":"","fda_regulated_device":"No","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 4","primary_compl_date":"12/31/2021 00:00:00","primary_outcomes":[{"outcome_description":"Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 c/mL at Week 24 will be assessed.","outcome_measure":"Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 copies/milliliter (c/mL) at Week 24","outcome_time_frame":"Week 24","outcome_safety_issue":null},{"outcome_description":"Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 c/mL at Week 48 will be assessed.","outcome_measure":"Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 c/mL at Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 c/mL at Week 96 will be assessed.","outcome_measure":"Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 c/mL at Week 96","outcome_time_frame":"Week 96","outcome_safety_issue":null},{"outcome_description":"Virologic control is defined as 2 consecutive HIV RNA levels >50 c/mL or HIV RNA >50c/mL followed by study treatment discontinuation or missing value. Number of subjects who lose virologic control will be assessed using a Kaplan-Meier Method.","outcome_measure":"Number of subjects who lose virologic control within the first 24 weeks after switching to a 2-DR","outcome_time_frame":"Week 24","outcome_safety_issue":null},{"outcome_description":"Virologic control is defined as 2 consecutive HIV RNA levels >50 c/mL or HIV RNA >50c/mL followed by study treatment discontinuation or missing value. Number of subjects who lose virologic control will be assessed using a Kaplan-Meier Method.","outcome_measure":"Number of subjects who lose virologic control within the first 48 weeks after switching to a 2-DR","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Virologic control is defined as 2 consecutive HIV RNA levels >50 c/mL or HIV RNA >50c/mL followed by study treatment discontinuation or missing value. Number of subjects who lose virologic control will be assessed using a Kaplan-Meier Method.","outcome_measure":"Number of subjects who lose virologic control within the first 96 weeks after switching to a 2-DR","outcome_time_frame":"Week 96","outcome_safety_issue":null},{"outcome_description":"Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 24 will be assessed.","outcome_measure":"Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 24","outcome_time_frame":"Week 24","outcome_safety_issue":null},{"outcome_description":"Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 48 will be assessed.","outcome_measure":"Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 96 will be assessed.","outcome_measure":"Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 96","outcome_time_frame":"Week 96","outcome_safety_issue":null}],"product_name":"GSK3365791;dolutegravir;dolutegravir/lamivudine;lamivudine;rilpivirine","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Subjects will be assessed for HIV RNA >200 c/mL after Week 24.","outcome_measure":"Number of subjects with HIV RNA >200 c/mL after 24 weeks","outcome_time_frame":"Week 24","outcome_safety_issue":null},{"outcome_description":"Subjects will be assessed for HIV RNA >200 c/mL after Week 48.","outcome_measure":"Number of subjects with HIV RNA >200 c/mL after 48 weeks","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Subjects will be assessed for HIV RNA >200 c/mL after Week 96.","outcome_measure":"Number of subjects with HIV RNA >200 c/mL after 96 weeks","outcome_time_frame":"Week 96","outcome_safety_issue":null},{"outcome_description":"Low level viremia is defined as virologic load >50 and <200 c/mL. Number of subjects with low level viremia will be assessed at indicated time points.","outcome_measure":"Number of subjects with low level viremia","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Virologic suppression is defined as viral load < 50 c/mL at the end of 6months/12months/18 months or as pre-specified.","outcome_measure":"Time to virologic suppression","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Time to virologic failure in the stable switch Population will be assessed. Subjects with virologic rebound or virologic non-response will be considered as failure.","outcome_measure":"Time to virologic failure","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Subjects with virologic rebound or virologic non-response will be considered as failure. Results of all HIV resistance tests performed before and during antiretroviral treatment will be evaluated to analyze resistance profile in case of virologic failure.","outcome_measure":"Number of subjects with resistance profile in case of virologic failure","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"A switching option for those with HIV RNA suppression on current treatment will be called as 'Stable switch'. Number of subjects with stable switch while virologically suppressed will be analyzed.","outcome_measure":"Number of subjects with stable switch while virologically suppressed","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Subjects with virologic rebound or virologic non-response will be considered as failure. Number of subjects with Switch after Failure will be analyzed.","outcome_measure":"Number of subjects with Switch after Failure","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Number of subjects switching for safety reasons including tolerability, toxicity and other reasons will be evaluated.","outcome_measure":"Number of subjects switching for safety reasons","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.","outcome_measure":"Number of subjects with adverse events (AEs) and serious AEs (SAEs)","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"All available CD4 and CD8 results since first starting 2DR treatment will be collected to analyze CD4+ and CD8+ T cell counts.","outcome_measure":"cluster of differentiation (CD)4+ and CD8+ T cell counts","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"All available CD4 and CD8 results since first starting 2DR treatment will be collected to analyze CD4/CD8 ratio at each time point","outcome_measure":"CD4/CD8 ratio at each time point","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"If number of failure allows, analysis to assess factors associated with success at week 96 in naïve and treatment experienced populations and with virologic failure in population switching with HIV RNA suppression will be analyzed.","outcome_measure":"Number of factors associated with plasma HIV-RNA > 50 c/mL","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A"]},"start_date":"11/18/2019 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207859"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}