Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Inf… (NCT05786937) | Clinical Trial Compass
UnknownPhase 1
Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals
Brazil30 participantsStarted 2023-06
Plain-language summary
The goal of this interventional study is to validate the strategy of adjuvant therapy with dendritic cells in HIV infection in chronically infected individuals. The main questions it aims to answer are related to the safety and tolerance of the intervention and the virological and immunological impact of immunotherapy with aDC1 in HIV-infected individuals. The study will include 30 diagnosed HIV-infected patients, using antiretroviral therapy, who will be immunized with aDC1 or placebo according to the arms of this study: G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART.
Who can participate
Age range
18 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:
* HIV infection confirmed according to the criteria of the Department of Chronic Diseases and Sexually Transmitted Infections of the Brazilian Health Ministry;
* Absence of the use of antineoplastic or corticosteroid therapies for a minimum period of six months prior to study entry;
* Absence of comorbidities considered uncontrolled by researchers;
* Viral load ≤ 40 copies/mL, stable (i.e., no \> 0.5 log) in the six months prior to the start of the study;
* Blood count of CD4 T lymphocytes ≥ 500 cells/μL, stable (i.e., \>25%) in the six months prior to the start of the study;
* Informed consent
Exclusion Criteria:
* Individuals without adequate venous access to the blood collection and apheresis procedure;
* Use of drugs or alcohol in a way that interferes with patients' ability to follow the study requirements;
* Pregnancy, breastfeeding or interest in becoming pregnant during the study period;
* Presence of any other condition that, in the evaluation of researchers is able to promote alteration of the immune system, as well as any disorders that could affect understanding in the process of informed consent.
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
Adverse events related to the study product
Timeframe: Six months
2
Plasma viral load setpoint after the intervention
Timeframe: Six months
3
Setpoint of CD4+ T lymphocyte count after the intervention