AIDS
Conditions
Interventions
Experimental Group:ICVAX: 1 mL: 2.0 mg, administered once at Week 0 and once at Week 26.
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Participants who have completed the Phase I study of ICVAX in the trial group; 2. Aged 18–60 years; 3. HIV-RNA viral load = 500 cells/µL during the screening period; 5. Willing to take effective contraceptive measures and practice absolutely safe sexual behavior with their partners during the clinical trial; women of childbearing age are willing to undergo blood pregnancy tests; 6. Understand the content of this trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Individuals who have previously interrupted antiretroviral therapy for more than 2 weeks, or who have developed resistance to one or two classes of antiviral drugs; 2. Individuals who have received any blood products, immunoglobulin products, or immunomodulatory agents within 12 weeks prior to screening; 3. Individuals who have used interferon, systemic corticosteroids, or other immunosuppressive agents within 12 weeks prior to screening (excluding topical use); 4. Any laboratory abnormalities, including: neutrophil count = 1.3×ULN, ALT or AST > 1.5×ULN; 5. Individuals who have received any approved vaccines within 12 weeks prior to screening; 6. Individuals with chronic hepatitis B virus (HBV) infection, defined as positive hepatitis B surface antigen (HBsAg); 7. Current active hepatitis C virus (HCV) carriers, defined as positive HCV RNA test with or without positive HCV antibody; 8. Individuals who have experienced any opportunistic infections or tumors requiring systemic treatment within 12 weeks prior to screening; individuals with a history of virus-related tumors such as Kaposi's sarcoma or lymphoma, including those with stable tumor control; or any medical events that the investigator deems may affect the evaluation of the safety and immunogenicity of the vaccine; 9. Individuals with a history of autoimmune diseases; severe allergic history, such as urticaria, dyspnea, edema, abdominal pain, etc., after drug administration, especially those who have had hypersensitivity reactions to any component of the study drug; 10. Individuals with suspected or active tuberculosis or those currently receiving anti-tuberculosis treatment (excluding those who have had it in the past but are cured); 11. Individuals with severe cardiovascular diseases such as myocardial infarction, heart failure, or high risk of cardiovascular diseases; severe chronic kidney diseases such as uremia; or malignant tumor patients; 12. Pregnant or breastfeeding women; individuals who plan to conceive within 2 years (including the participant and their spouse); 13. Any history or clinical manifestations of physical or mental diseases that may affect the participant's ability to complete the study; 14. Individuals whom the investigator deems unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants not requiring restart of ART treatment at Week 52;All adverse events reported voluntarily by subjects, directly observed by investigators, or obtained by investigators through non-induced inquiries during the 52-week clinical trial.;Abnormal clinical symptoms, vital signs, as well as laboratory and imaging examination results within 52 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with HIV-RNA viral load < 200 copies/mL at Week 52;Percentage of participants with HIV-RNA viral load < 50 copies/mL at Week 52;Changes in immune function (CD4+ and CD8+) within 52 weeks;Median time to viral rebound after Antiviral Treatment Interruption (ATI);Median peak viral load after Antiviral Treatment Interruption (ATI); | — |
Countries
China
Contacts
Public ContactLu Hongzhou
Shenzhen Third People's Hospital
Outcome results
None listed