[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100216235":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":41,"centralContacts":46,"locations":47,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":46,"enrollmentInfo":76,"targetDuration":46,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":46,"overallStatus":86,"whyStopped":46,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Bionor Immuno AS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A","OTHER","Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg\u002Fm2 on days 0, 7, and 14.\n\nPost-activation phase of \\~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir.",[13],"Drug: Romidepsin",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B","Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).\n\nA viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg\u002Fm2) followed by a post-treatment observation phase of \\~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.\n\nA monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33).",[13,18,19],"Biological: Vacc-4x","Biological: rhuGM-CSF",[21,28,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Romidepsin","Latency reversing agent",[9,15],[27],"Istodax®",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","Vacc-4x","Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.",[15],[34],"A combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"rhuGM-CSF","Granulocyte macrophage colony stimulating factor as a local adjuvant",[15],[40],"Leukine®",[42],{"name":43,"affiliation":44,"role":45},"Lars Jørgen Østergaard, MD, PhD","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",null,[48],{"facility":49,"status":46,"city":50,"state":46,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":46},"Aarhus University Hospital, Skejby Sygehus","Aarhus N","8200","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],10.17317,56.20367,{"lat":58,"lon":57},{"type":61,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[63],{"name":64,"class":6},"Celgene Corporation","100216235","phase-1-safety-and-efficacy-of-romidepsin-and-the-therapeutic-vaccine-vacc-4x-for-reduction-of-the-latent-hiv-1-reservoir-100216235",true,"NCT02092116","Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir","An Open Phase I\u002FIIa Study to Evaluate the Safety and Effect of Therapeutic HIV-1 Immunization Using Vacc-4x + rhuGM-CSF and HIV-1 Reactivation Using Romidepsin on the Viral Reservoir in Virologically Suppressed HIV-1 Infected Adults on cART","REDUC","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Currently receiving cART and having received cART for a minimum of 1 year\n3. HIV-1 plasma RNA \\\u003C50 copies\u002FmL for at least 1 year (excluding viral load blips)\n4. CD4 T cell count ≥500 cells\u002Fmm3\n\nExclusion Criteria:\n\n1. CD4 T cell count nadir \\\u003C200 cells\u002Fmm3\n2. Previous treatment with an HDACi (Histone deacetylase inhibitor) within the previous 6 months\n3. Any evidence of an active AIDS-defining opportunistic infection, active HBV or HCV co-infection, significant cardiac disease, malignancy, transplantation, insulin dependent diabetes mellitus or other protocol defined excluded medical condition\n4. Use of any protocol defined contraindicated medication or vaccination\n5. Unacceptable values of the hematologic and clinical chemistry parameters as defined in the protocol.\n6. Males or females who are unwilling or unable to use protocol defined methods of contraception",false,"ALL","18 Years",{"count":77,"type":78},26,"ACTUAL","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The REDUC trial's objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate the infected cells.",[85],"HIV I Infection","COMPLETED","2017-01-11",{"date":89,"type":78},"2017-03-01",{"date":91,"type":46},"2014-03",{"date":93,"type":78},"2015-12",{"name":5,"class":6},1]