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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.
Dendritic cell based immunotherapy is a potential tool to stimulate a specific immune response, as a complementary treatment for HIV-infected individuals using ART. Polarizing DCs are capable to produce high levels of IL-12p70 and induce a strong cytotoxic response that is very useful in viral infections. In this context, we propose to study aDC1 pulsed with relevant HIV peptides for treatment of 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. Autologous PBMCs will be collected for baseline parameters and vaccine will be inoculated in 3 doses (with 4 week interval). Three weeks after 3th vaccine inoculation, patients will be followed for 6 months and blood and biopsis samples will be collected for different parameters measurement as immune activation, immunogenicity, humoral response, mucosal cellular immunity and virologic profile and viral reservoir analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The participants will receive a placebo, which is the excipient solution of aDC1 cell suspension consisting of a commercial ringer“s lactate solution. |
|
| aDC1immunization | Active Comparator | The participants will be immunized with aDC1 unpulsed with HIV peptides. |
|
| aDC1 immunization with analytical treatment interruption of ART | Experimental | The participants will be immunized with aDC1 pulsed with HIV peptides. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides | Biological | Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to the study product | Number of participants with adverse events related to the study product | Six months |
| Plasma viral load setpoint after the intervention | Number of participants with changes in the plasma viral load setpoint after the intervention | Six months |
| Setpoint of CD4+ T lymphocyte count after the intervention | Number of participants with changes in the setpoint of CD4+ T lymphocyte count after the intervention | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto JosƩ DS Duarte, PhD | Contact | +55 (11) 3061-7499 | adjsduar@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Alberto JosƩ DS Duarte, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClĆnicas da Faculdade de Medicina da USP | SĆ£o Paulo | 05403-000 | Brazil |
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Phase I, double-blind, randomized study with three parallel groups as follows: : G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART.
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To avoid bias in evaluating the results, the research volunteer and the team that will perform the application of the vaccine product will be blind in the present study. The team responsible for coordinating the project will not be blind.
| Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides | Biological | Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides |
|
| Commercial ringer“s lactate solution | Other | Placebo |
|
| ID | Term |
|---|---|
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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