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

Phase

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

Foreseen duration

1 year

Type of procedure

Contained use and Deliberate release

Current status

Authorized

Pharmaceutical study code

THV01-11-1

Information for the public

B/BE/12/BVW1 - Public information sheet (written by the notifier)

B/BE/12/BVW1 - Fiche d'information destinée au public (préparée par le notifiant)

B/BE/12/BVW1 - Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)

Information related to the decision procedure

B/BE/12/BVW1 - Advice Biosafety Advisory Council

11 September 2012: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.

B/BE/12/BVW1 - Decision of the Federal Minister (FINAL DECISION)

18 October 2012: The Federal Minister gives a final decision (positive with conditions) for this trial.