Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus

Study Overview
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Brief Summary
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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.

Official Title
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Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus

Conditions
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HIV Infection

Intervention / Treatment
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* Biological: DC
* Biological: DC10e6+HIV-AT2
* Biological: DC10e7+HIV-AT2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (a) DC<br>Autologous dendritic cells (3x10e7) | Biological: DC<br>* Autologous dendritic cells (3x10e7)<br>|
| Active Comparator: (b) DC 10e6+HIV-AT2<br>Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV | Biological: DC10e6+HIV-AT2<br>* Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV<br>|
| Active Comparator: (c) DC 10e7+HIV-AT2<br>Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV | Biological: DC10e7+HIV-AT2<br>* Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ≥ grade 3 adverse events related to product | AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004 | 51 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with change in plasma viral load from baseline, over the observation period | Log10 change in HIV RNA | Baseline to 51 weeks | 
| Number of participants with change in CD4+T cells from baseline, over the observation period | Absolute number change of CD4+T cells | Baseline to 51 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, immunotherapy, clinical trial, dendritic cell