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

Phase 1

Completed

• Conditions: HIV Infection
• Interventions: Biological: DC10e7+HIV-AT2; Biological: DC10e6+HIV-AT2; Biological: DC

• Registration Number: NCT02766049
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2016-04-01
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-09
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(c) DC 10e7+HIV-AT2	DC10e7+HIV-AT2	Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV
(b) DC 10e6+HIV-AT2	DC10e6+HIV-AT2	Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
(a) DC	DC	Autologous dendritic cells (3x10e7)

Primary Outcome Measures

Name	Time	Method
Number of participants with ≥ grade 3 adverse events related to product	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

Name	Time	Method
Number of participants with change in plasma viral load from baseline, over the observation period	Baseline to 51 weeks	Log10 change in HIV RNA
Number of participants with change in CD4+T cells from baseline, over the observation period	Baseline to 51 weeks	Absolute number change of CD4+T cells