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B-GT/10: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination with ALVAC-HIV (vCP-1452) and Remune or placebo while maintaining optimal therapeutic viral suppression |
Company or sponsor |
Sponsor of the study: Glaxo Wellcome; Manufacturer of the GMO: Aventis-Pasteur S.A. |
Pharmaceutical study code |
PROB3005 |
Phase |
III |
Unicenter/multicenter study |
unicenter |
| Clinical data | see table 2 |
Installation |
Centre Hospitalier Universitaire St Pierre, Brussels |
Authorisation procedure |
contained use, new operation (see relevant regulation) |
Application number |
SBB 219 2000/1002 |
User(s) |
Dr. Nathan Clumeck |
Receipt date |
13/10/2000 |
Biosafety Council meeting date |
6/12/2000 |
Authorisation date |
2/05/2002 |
Status |
unknown |
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