[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-immunodeficiency-virus-i-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-immunodeficiency-virus-i-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100633708","phase-1-hiv-therapeutic-dna-vaccine-icvax-phase-i-clinical-trial-in-hong-kong-100633708",false,"NCT07530198","HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong","HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong: Evaluation of Immunogenicity and Safety of ICVAX in ART-treated Clinically Stable HIV-infected Patients","Inclusion Criteria:\n\n1. Tested positive for HIV-1 antibody;\n2. Aged 18-60, both male and female;\n3. BMI (body mass index) in between 18.5 and 24.9 kg\u002Fm2 (including upper and lower limits);\n4. Received ART for ≥12 months; no drug resistance occurred during this treatment period;\n5. Had \\\u003C50 copies\u002Fml of plasma HIV RNA for at least (≥) 12 months prior to screening visit;\n6. Had ≥350 cells\u002FμL of CD4+ T cells in the past 6 months and \\>200 cells\u002FμL of CD4+ T cells before initiation of ART;\n7. Adopted contraception method approved by the investigator from screening period until the end of study;\n8. Understand the study and voluntarily sign the ICF.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding or those who plan to give birth in coming two years (including the subject and his\u002Fher spouse);\n2. ART has been suspended for more than 2 weeks continuously since ART initiation;\n3. Participated in other clinical trials within 24 weeks before the screening visit;\n4. Has any opportunistic infections or opportunistic tumors that require systemic treatment within 30 days before being recruited; Has any medical events that the investigator believes will affect the safety and immunogenicity evaluation of the drug;\n5. Has a history of autoimmune diseases; Has hypersensitivity to the components of this drug including ICVAX recombinant plasmid, NaCl, Na2HPO4 and NaH2PO4·H2O, and shows severe allergies, such as dyspnea, edema and other symptoms after administration;\n6. Received approved vaccines within the past 3 months;\n7. Received any blood products, immunoglobulin products, or immunosuppressants within 12 weeks before being recruited;\n8. Used interferon, systemic corticosteroids, or other immunosuppressants within the last 3 months (except local application);\n9. Positive Hepatitis B surface antigen (HBsAg) within 12 months, or positive Hepatitis C virus antibody (HCV Ab) at screening with confirmatory HCV RNA positive;\n10. Has any abnormal laboratory results including: neutrophil \\\u003C1×109\u002FL, serum creatinine \\> ULN, ALT or AST \\>1.5×ULN, hemoglobin \\\u003C 11g\u002FdL;\n11. Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;\n12. Sensitive to electrical pulse stimulation, such as those who are implanted with pacemaker\u002F Automatic Implantable Cardioverter Defibrillator (AICD), or those who have wearable medical electronic devices including electrocardiogram;\n13. Needle phobia;\n14. Have contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or currently receiving anticoagulation therapy;\n15. The investigator considers that he\u002Fshe is not suitable to participate in this trial.","ALL","18 Years","60 Years",{"count":20,"type":21},22,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this randomized clinical trial is to evaluate the safety and immunogenicity of the HIV Therapeutic DNA Vaccine (ICVAX) in participants with HIV-1 infection under antiretroviral therapy (ART). The study compares three delivery methods - Teresa -EPT I, PharmaJet Tropis, and PapiVax TriGrid EP - to induce antigen-specific T cell responses in the participants.\n\nThe primary objectives are to evaluate the safety of ICVAX delivered using three different devices in the participants within the period Day 0-Day 336, and to evaluate the antigen-specific T cell responses induced by ICVAX in the participants within the period Day 0-Day 168.\n\nThe participants will receive four injections of ICVAX administered at 4-week intervals. Following the final dose, participants will be monitored for 36 weeks.",[27,28],"Human Immunodeficiency Virus","Human Immunodeficiency Virus I Infection",[30,31,32,33],"ICVAX","HIV","AIDS","DNA Vaccine","RECRUITING","2026-04-08",{"date":37,"type":38},"2026-04-15","ACTUAL",{"date":40,"type":38},"2026-03-30",{"date":42,"type":21},"2027-07-31",{"name":44,"class":45},"Immuno Cure Holding (HK) Limited","INDUSTRY"]