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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":"NCT03518060","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"","masked_caregiver":"","masked_investigator":"","masked_subject":"","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"None","acronym":"JUNGLE","allocation":"","arm_groups":[{"arm_group_label":"Subjects receiving Juluca","arm_group_description":"Approximately 250 virologically suppressed HIV positive subjects on a stable antiretroviral regimen as indicated in local SmPC of Juluca will be included in the study. The subjects will be followed for approximately 3 years during routine clinical practice.","arm_type":""}],"assignment":"","brief_summary":"This is a prospective, non‐interventional, single‐arm, multi‐center study aimed at gathering real‐world data on Juluca use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive subjects in Germany. Approximately 250 virologically suppressed HIV positive subjects on stable antiretroviral therapy (ART) will be included in the study at the discretion of treating physician. Eligible subjects will be followed up for approximately 3 years and data will be collected during routine clinical care.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Dolutegravir/Rilpivirine, antiretroviral efficacy study using real-world data in subjects with human immunodeficiency virus (HIV)-1","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:24:26","criteria":"Inclusion Criteria: - >=18 years of age. - Documented HIV‐1 infection. - Virologically suppressed (HIV‐1 ribonucleic acid [RNA] <50 c/mL for at least 6 months) - Prescription for Juluca was issued independently from entering this study. - Ability to understand informed consent form and other relevant study documents Exclusion Criteria: - Any contraindication according to Juluca SmPC. - Documented viral load >50 c/mL at any time point within 6 months prior to inclusion into this study. - History of treatment failure. - Known or suspected substitutions associated with resistance to any Non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI). - Any ART for the treatment of HIV‐1 in addition to Juluca. - Hepatitis B virus (HBV)‐co-infection. - Current participation in the ongoing non‐interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication. - Previous participation in clinical trials involving Juluca.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"","display_phase_internal":"","display_status":"Planned","display_status_internal":"RECSTATUS_O_PLANNED","endpoint":"","enrollment":"250","exclusion":"","gender":"All","gender_based":"No","gender_description":"","healthy_volunteers":"No","id":"6425ec24-d503-5770-b052-c1c0a50d69fc","internal":{"content":null,"contentDigest":"71a6494d4aea6bfe7d229e110c42beeb","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - >=18 years of age. - Documented HIV‐1 infection. - Virologically suppressed (HIV‐1 ribonucleic acid [RNA] <50 c/mL for at least 6 months) - Prescription for Juluca was issued independently from entering this study. - Ability to understand informed consent form and other relevant study documents Exclusion Criteria: - Any contraindication according to Juluca SmPC. - Documented viral load >50 c/mL at any time point within 6 months prior to inclusion into this study. - History of treatment failure. - Known or suspected substitutions associated with resistance to any Non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI). - Any ART for the treatment of HIV‐1 in addition to Juluca. - Hepatitis B virus (HBV)‐co-infection. - Current participation in the ongoing non‐interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication. - Previous participation in clinical trials involving Juluca.","interventions":[{"arm_group_label":"Subjects receiving Juluca","intervention_description":"Juluca is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).","intervention_name":"Juluca","intervention_type":"Drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["2 drug regimen","Juluca","Rilpivirine","Dolutegravir","Antiretroviral","One pill regimen"],"last_follow_up_date":"12/01/2021 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"10/01/2018 22:48:17","number_of_arms":"","observational_design":{"biospecimen_description":"","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":"Durability of Antiretroviral Suppression and the Real World Clinical Profile of the Novel 2‐Drug Regimen Juluca, a Onepill‐Regimen Consisting of Dolutegravir and Rilpivirine, in Routine Clinical Care in Germany","org_study_id":"208982","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Not yet recruiting - Observational","oversight_info":{"exported_from_us":"","fda_regulated_device":"No","fda_regulated_drug":"No","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"","primary_compl_date":"12/01/2021 00:00:00","primary_outcomes":[{"outcome_description":"Sustained virological suppression is defined as viral load (VL) <50 copies/milliliter (c/mL) or if between 50 to 200 c/mL with a subsequent next available measurement (within 120 days) <50 c/mL at year 1, 2 and 3.","outcome_measure":"Number of subjects with sustained virologic suppression","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Low level viremia is defined as a VL measurement >50 to <200 c/mL. Number of subjects with low level viremia will be presented.","outcome_measure":"Number of subjects with low level viremia","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"Number of subjects with VL >50 c/mL with emergent resistance mutations will be presented.","outcome_measure":"Number of subjects with VL >50 c/mL with emergent resistance mutations","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"Virologic rebound is defined as two consecutive VL measurements of >=200 c/mL. Number of subjects with virologic rebound will be presented.","outcome_measure":"Number of subjects with virologic rebound","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"Number of subjects with two consecutive measurements of >=200 c/mL, or treatment switch due to VF or due to intolerability as determined at the discretion of the physician will be presented.","outcome_measure":"Number of subjects with two consecutive measurements of >=200 c/mL, or treatment switch due to virological failure (VF) or due to intolerability as determined at the discretion of the physician","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"Number of subjects with VL <50 c/mL will be presented.","outcome_measure":"Number of subjects with VL <50 c/mL","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"Number of therapeutic monitoring measures in HIV-infected subjects will be recorded.","outcome_measure":"Number of monitoring measures","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.","outcome_measure":"Number and frequency of serious adverse events (SAEs)","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out.","outcome_measure":"Number and frequency of adverse drug reactions (ADRs)","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"Adherence refers to missed monthly doses. At Baseline and at each Follow‐up visit, subjects will be asked to give an estimation of their level of adherence to their ART.","outcome_measure":"Adherence to therapy","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"Impact on lipid metabolism will be assessed by changes in lipid laboratory values. Changes in lipid laboratory values will be recorded.","outcome_measure":"Change in lipid laboratory values","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"The HIV TSQ is a 10‐item‐self‐reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc.","outcome_measure":"Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (TSQ)","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"HIV Symptom Distress Module (also called the HIV Symptom Index or Symptoms Impact Questionnaire) is a 20‐item self‐reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.","outcome_measure":"Change in symptom distress based on HIV Symptom Distress Module questionnaire","outcome_time_frame":"Up to 3 years","outcome_safety_issue":null},{"outcome_description":"The reasons for switch to Juluca will be recorded.","outcome_measure":"Reason for switch to Juluca","outcome_time_frame":"Baseline","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["MUC Research GmbH"]},"start_date":"06/01/2018 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"208982"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}