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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766049
• Other study ID #: CAPPesq-0239/09
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 1, 2016
• Last updated: July 19, 2016
• Start date: February 2010
• Est. completion date: May 2014

Study information

• Verified date: May 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Biological:
• DC
Autologous dendritic cells (3x10e7)
• DC10e6+HIV-AT2
Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
• DC10e7+HIV-AT2
Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

References & Publications (2)

Lu W, Arraes LC, Ferreira WT, Andrieu JM. Therapeutic dendritic-cell vaccine for chronic HIV-1 infection. Nat Med. 2004 Dec;10(12):1359-65. Epub 2004 Nov 28. — View Citation

Oshiro TM, de Almeida A, da Silva Duarte AJ. Dendritic cell immunotherapy for HIV infection: from theory to reality. Immunotherapy. 2009 Nov;1(6):1039-51. doi: 10.2217/imt.09.68. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of participants with change in plasma viral load from baseline, over the observation period	Log10 change in HIV RNA	Baseline to 51 weeks	Yes
Secondary	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	Yes