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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events at week 36 [Safety and Tolerability]
. 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;
. Received approved vaccines within the past 3 months;
. Received any blood products, immunoglobulin products, or immunosuppressants within 12 weeks before being recruited;
. Used interferon, systemic corticosteroids, or other immunosuppressants within the last 3 months (except for local application only);