A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy

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Study title: 
A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy
EU record number: 
B/BE/12/BVW1
EudraCT number: 
2011-006260-52
Pharmaceutical study code: 
THV01-11-1
Company / Sponsor: 
TheraVectys
Phase: 
I
Treated organism: 
Humans
Indication category: 
Infectious disease
Disease: 
AIDS
Therapeutic approach: 
Immunotherapy
Genetic modification: 
genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
Method of transfer of nucleic acid of interest: 
Human immunodeficiency virus (HIV): NL4-3 strain of HIV-1
Administered biological material: 
non replication comptent lentivirus
Route of administration: 
intramuscular
Locations in Belgium: 
CHU Liège, CHU St Pierre Brussels
Nr of subjects: 
36
Foreseen duration: 
1 year
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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