Trial | NCT01549119  Report issue

Title

Phase I/IIa Dose-escalation Clinical Study of VAC-3S
Multicentre, Randomized, Placebo-controlled, Double-blind, Phase I/IIa Dose-escalation Clinical Study of a Therapeutic Vaccine (VAC-3S) Intended to Confer Protection Against Immunopathological Effects of HIV-1 in Infected Patients

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vac-3s ...

  • Study Participants

    33
The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.
Study Started
Feb 29
2012
Primary Completion
Feb 28
2013
Study Completion
Dec 31
2014
Last Update
Feb 02
2015
Estimate

Biological VAC-3S

Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart

Biological Placebo

Comparison with experimental vaccine

Low dose VAC-3S Experimental

Medium dose VAC-3S Experimental

High dose VAC-3S Experimental

Placebo Placebo Comparator

Double-dose VAC-3S Experimental

Criteria 

Inclusion Criteria:

HIV-1 infected patient
Age between 18 and 55 years
ART (AntiRetroviral Therapy) initiation 1 year ago
Plasma HIV RNA below 50 copies per ml on three sequential occasions including V-1 in the past 12 months
CD4 T cell count above or equal to 200 cells per mm3,
Nadir CD4 T cell count above or equal to 100 cells per mm3,
Contraception in women with child-bearing potential

Exclusion Criteria:

Any ART change within a month preceding screening.
Chronic active liver disease, HIV-Hepatitis Coinfection.
Immunotherapy in the past year, immunosuppressive treatment within the past month.
History of auto-immune disease
No Results Posted