[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100392121":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":44,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaccine group","EXPERIMENTAL","ATI\\_extension will keep allocation from AELIX-002 for a separate description of the results.",[13],"Biological: Vaccine + extension of the ATI period",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo group","PLACEBO_COMPARATOR",[18],"Other: Placebo + extension of the ATI period",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Vaccine + extension of the ATI period","During the AELIX-002 trial participants received the following: DNA.HTI at weeks 0, 4, and 8 and MVA.HTI at weeks 12 and 20 (DDDMM) followed by ChAdOx1.HTI at weeks 0 and 12 and MVA.HTI at week 24 (CCM), starting at least 24 weeks after MVA.HTI week 20. After that, on ATI\\_extension trial, ATI will be extended for 48 weeks.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo + extension of the ATI period","During the AELIX-002 trial participants received the following: Normal saline solution at weeks 0, 4, 8, 12, and 20 (PPPPP) followed by normal saline solution at weeks 0, 12 and 24 (PPP), starting at least 24 weeks after week 20 administration. After that, on ATI\\_extension trial, ATI will be extended for 48 weeks.",[15],[31],{"facility":32,"status":25,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":25},"Germans Trias i Pujol Hospital","Badalona","Barcelona","08916","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],2.24741,41.45004,{"lat":42,"lon":41},{"type":45,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[47],{"name":48,"class":49},"Aelix Therapeutics","INDUSTRY","100392121","phase-1-study-to-assess-the-safety-and-durability-of-viral-control-beyond-24-weeks-of-analytical-treatment-interruption-after-the-administration-of-candidate-hiv-1-vaccines-dnahti-mvahti-and-chadox1hti-or-placebo-in-early-treated-hiv-1-positive-individuals-ati-extension-of-aelix-002-study-100392121",false,"NCT04385875","Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study)","Inclusion Criteria:\n\n* Participants of the AELIX-002 clinical trial at week 24 of ATI:\n\n  1. Willing to continue the ATI up to 1 year.\n  2. With pVL \\\u003C2,000 copies\u002Fml at week 24 of ATI on the AELIX-002 study.\n  3. CD4 count ≥350 cells\u002Fmm3 at week 24 of ATI on the AELIX-002study.\n  4. Willing to comply with the measures to prevent HIV transmission and reinfection required by the protocol.\n  5. Available for follow-up for the planned duration of the ATI period of this study.\n  6. Willing to accept blood draws and collect stool at time points specified in the Schedule of Procedures.\n  7. If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device\n\n     (IUD), or anatomical sterility in self or partner1) during the ATI and until her pVL is \\\u003C50 copies\u002Fml after cART resumption.\n  8. If heterosexually active male; using an effective method of contraception (anatomical sterility in self) or agree on the use of an effective method of contraception by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical\n\n     sterility1) during the ATI and until his pVL is \\\u003C50 copies\u002Fml after cART resumption.\n  9. Not willing to donate blood during the study.\n  10. Participants who understand the information provided, in the opinion of the investigator.\n\n      Exclusion Criteria:\n\n  1- Pregnancy or breastfeeding.\n\n  2\\. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.\n\n  3\\. Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.\n\n  4\\. Active hepatitis B or C at week 24 of ATI on the AELIX-002 study.\n\n  5\\. Risk of HIV transmission (i.e. repeated STI during the AELIX-002 ATI period or reported unprotected anal sex).","ALL","18 Years","40 Years",{"count":60,"type":61},6,"ACTUAL","INTERVENTIONAL",[64],"PHASE1","The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies\u002FmL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.",[67],"HIV-1 Infection",[69,70,71,72,73],"HIV-1 infection","Therapeutic Vaccines","HTI","Antiretroviral Treatment Interruption (ATI)","Viral control","COMPLETED","2022-05-03",{"date":77,"type":61},"2022-05-04",{"date":79,"type":61},"2020-06-01",{"date":81,"type":61},"2022-02-10",{"name":5,"class":6},1]