ICVAX as a HIV Therapeutic DNA Vaccine (NCT06253533) | Clinical Trial Compass
CompletedPhase 1
ICVAX as a HIV Therapeutic DNA Vaccine
China45 participantsStarted 2023-02-14
Plain-language summary
The clinical trial is a dose-escalation, randomized, double-blind, placebo-controlled phase I study at a single center to evaluate the safety, tolerability and immunogenicity of HIV Therapeutic DNA Vaccine, ICVAX, in clinically stable HIV patients under ART treatment.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Tested positive for HIV-1 infection;
✓. Aged 18-50, both male and female;
✓. Received ART treatment for ≥ 12 months with no occurrence of drug resistance during the treatment period
✓. Had \<50 copies/ml of plasma HIV RNA for at least (≥) 12 months prior to screening visit;
✓. Had ≥350 cells/μL of CD4+ T cells in the past 6 months and \>200 cells/μL of CD4+ T cells at the beginning of ART;
✓. Adopted contraception method approved by the investigator from 14 days before the first dose to at least 12 weeks after the last dose;
✓. Understands the study and voluntarily sign the ICF
Exclusion criteria
✕. Women who are pregnant or breastfeeding or those who plan to give birth in coming two years (including the subject and his/her spouse);
✕. ART has been suspended for more than 2 weeks in the past;
✕. Participated in other clinical trials within 24 weeks before the screening visit;
✕. Has any opportunistic infections or opportunistic tumors that require systemic treatment within 30 days before being recruited; Has any medical event that the investigator believes will affect the safety and immunogenicity evaluation of the drug;
✕. Has a history of autoimmune diseases; a history of severe allergies, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially those who have hypersensitivity to the drug components of this study;
What they're measuring
1
Incidence of adverse events at week 36 [Safety and Tolerability]