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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001795-22 | EudraCT Number |
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single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective, placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with pegylated interferon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCV3 | Experimental | Autologus differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus |
|
| DCV3 with PEG-INF | Experimental | Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG-INF |
|
| CD placebo | Placebo Comparator | Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded |
|
| CD placebo + PEG-INF | Placebo Comparator | Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG-INF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCV3 | Biological | Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus. Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with adverse events of grade 3 or higher |
| 28 weeks |
| Virological | Proportion of patients with undetectable viral load (<37 copies / mL) at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events grade 1 and 2 within 14 days after each immunization (weeks 2, 4 and 6) | 6 weeks | |
| Changes in the specific immune response | Measured by ELISPOT visits in weeks 2, 4, 8, 12, 16 and 28 compared to baseline and screening for dendritic cell vaccine and pegylated interferon. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic | Barcelona | España | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34858423 | Derived | Leal L, Couto E, Sanchez-Palomino S, Climent N, Fernandez I, Miralles L, Romero Y, Gonzalez T, Maleno MJ, Pano B, Pich J, Nicolau C, Gatell JM, Plana M, Garcia F; DCV3-RISVAC04 Study Group. Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon alpha-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial. Front Immunol. 2021 Nov 11;12:767370. doi: 10.3389/fimmu.2021.767370. eCollection 2021. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| DCV3 with PEG-INF | Biological | Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG_INF Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4 and INF during weeks 4,5 and 6 |
|
| Placebo | Biological | Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4 |
|
| Placebo with PEG-INF | Biological | Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG_INF Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4 and INF during weeks 4,5 and 6. |
|
| 28 weeks |
| Changes in levels of viral reservoir. | Measure the proviral DNA visits in the weeks -44, -36, 4, 8, 12, 16 and 28 compared to baseline and screening. | 28 weeks |
| Proportion of patients with changes in any value of the levels of inflammatory markers, microbial translocation and immune activation | In visits at weeks 4, 16 and 28 compared compared to baseline and screening | 28 weeks |
| Proportion of patients with viral rebound | Two consecutive obtaining measurements of plasma viral load> 37 copies / mL separated by at least 15 days after discontinuation of antiretroviral therapy. | 15 days |
| Proportion of patients with autoimmunity markers induced by the vaccine as measured by: antithyroid antibodies (antithyroglobulin, antithyroid peroxidase), antinuclear antibodies, antiphospholipid antibodies and rheumatoid factors. | Evaluation on autoimmunity with antithyroid antibodies (antithyroglobulin, antithyroid peroxidase), antinuclear antibodies, antiphospholipid antibodies and rheumatoid factor at screening, baseline and week 16. | 16 weeks |
| Changes in the transcriptome of patients visits weeks 4, 16 and 28 compared to baseline (week -12) | Weeks 4, 16 and 28 compared to baseline | 28 weeks |
| Evaluation of the specific immune response trought IFN-gamma production in vitro at screening and baseline | Proportion of patients with IFN-gamma production in vitro measured by ELISPOT at screening and baseline | week 0 |
| Evaluation of the specific immune response thought dendritic cell maturation markers in vitro at screening and baseline | Proportion of patients with dendritic cell maturation markers in vitro measured by flow cytometry at screening and baseline | week 0 |
| Evaluation of the specific immune response thought T-cell proliferation in vitro at screening and baseline | Proportion of patients with T-cell proliferation in vitro measured by CFSE (carboxyfluorescein succinimidyl ester) at screening and baseline | week 0 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |