Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
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ClinicalTrials.gov Identifier: NCT02766049 |
Recruitment Status
:
Completed
First Posted
: May 9, 2016
Last Update Posted
: July 20, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Biological: DC Biological: DC10e6+HIV-AT2 Biological: DC10e7+HIV-AT2 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: (a) DC
Autologous dendritic cells (3x10e7)
|
Biological: DC
Autologous dendritic cells (3x10e7)
|
Active Comparator: (b) DC 10e6+HIV-AT2
Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
|
Biological: DC10e6+HIV-AT2
Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
|
Active Comparator: (c) DC 10e7+HIV-AT2
Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV
|
Biological: DC10e7+HIV-AT2
Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV
|
- Number of participants with ≥ grade 3 adverse events related to product [ Time Frame: 51 weeks ]AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
- Number of participants with change in plasma viral load from baseline, over the observation period [ Time Frame: Baseline to 51 weeks ]Log10 change in HIV RNA
- Number of participants with change in CD4+T cells from baseline, over the observation period [ Time Frame: Baseline to 51 weeks ]Absolute number change of CD4+T cells

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with HIV infection;
- absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
- plasma viral load ≥ 1,000 copies / mL, stable (ie no variation > 0.5 log) in the six months before the start of the study;
- blood CD4+ T cells ≥ 350 /mL, stable (ie no variation > 25%) in the six months before the start of the study.
Exclusion Criteria:
- individuals without proper venous access for blood and apheresis collection procedure.
- use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
- history of diagnosis of HIV infection <01 years;
- pregnancy or breast-feeding;
- use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;
- presence of chronic diseases, such as infection with hepatitis B (HBV) and C (HCV), human T-lymphotropic virus (HTLV) I / II or any condition that promotes immune system dysfunction, with the exception of HIV infection.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766049
Principal Investigator: | Alberto JS Duarte, Professor | University of Sao Paulo |
Publications:
Responsible Party: | University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier: | NCT02766049 History of Changes |
Other Study ID Numbers: |
CAPPesq-0239/09 |
First Posted: | May 9, 2016 Key Record Dates |
Last Update Posted: | July 20, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by University of Sao Paulo General Hospital:
HIV immunotherapy clinical trial dendritic cell |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |