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Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
This study has been completed.
Sponsor:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02766049
First received: April 1, 2016
Last updated: July 19, 2016
Last verified: May 2016
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Purpose
The aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable impact was also assessed.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infection | Biological: DC Biological: DC10e6+HIV-AT2 Biological: DC10e7+HIV-AT2 | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo General Hospital:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 19 |
| Study Start Date: | February 2010 |
| Study Completion Date: | May 2014 |
| Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02766049
Please refer to this study by its ClinicalTrials.gov identifier: NCT02766049
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
| Principal Investigator: | Alberto JS Duarte, Professor | University of Sao Paulo |
More Information
Publications:
| Responsible Party: | University of Sao Paulo General Hospital |
| ClinicalTrials.gov Identifier: | NCT02766049 History of Changes |
| Other Study ID Numbers: |
CAPPesq-0239/09 |
| Study First Received: | April 1, 2016 |
| Last Updated: | July 19, 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 |
ClinicalTrials.gov processed this record on September 19, 2017