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Successful new strategy based on dual therapy shows non-inferiority compared to standard of care triple combination in ARV-naïve patients
GARDEL Study results, designed, organized and directed from Argentina, were presented today at the European AIDS Conferences in Brussels.
Brussels, October 18, 2013 - In the framework of the 14th European AIDS Conference, researchers presented results of the
48-week GARDEL study, showing that a regimen containing two drugs can achieve similar results to the traditional approach with three
drugs, which offers a simpler alternative with fewer side effects and less monitoring requirement.
This international multi-site, randomized, open-label study enrolled 535 patients from 27 centers in Argentina, Spain, USA, Chile,
Mexico and Peru, and was designed, organized and led by Fundacion Huesped of Buenos Aires, the most important HIV research center in
Argentina. The GARDEL study compared the response of two groups of treatment-naive patients the comparator arm received the
combination of standard triple therapy containing Lopinavir/ritonavir plus 2 NRTIs in fixed-dose combination, while the
study arm was treated with Lopinavir / Ritonavir (LPV / r) and Lamivudine (3TC).
"For the research team at Fundacion Huesped, the GARDEL study results are doubly satisfying. First, we have added a potential treatment
alternative that can be applied in different parts of the world as a safe regimen with a low risk of resistance.
And, furthermore, we have shown that we are capable of designing and coordinating an international multicentre
study which involved 535 patients from Europe, the U.S. and Latin America", said Dr. Pedro Cahn,
Chief Scientist and Principal Investigator from Fundacion Huesped.
The results: 88.3 % of patients treated with the novel strategy succeeded in bringing their viral load to undetectable levels,
versus 83.7 % with traditional therapy; thus demonstrating non-inferiority. Also, the recovery of CD4 cells was similar between
the two approaches.
This project was made possible by financial support from Abbvie and the provision of drugs by Abbvie and GSK - ViiV,
in addition to Fundacion Huesped's own contributions generated through small monthly donations from thousands of
Argentinian supporters.
About Fundacion Huesped
Fundacion Huesped is an Argentinian organization that, since 1989, works in response to HIV/AIDS, not only as a biological disease,
but also as an important social issue. The Foundation provides access to information, education and prevention; forges a
committed and supportive social conscience; provides research and training to health professionals, and improves social
and health services, including protection against discrimination. More info: www.huesped.org.ar/english .
For Media inquires:
Debora Fiore (Communications Coordinator): +54 911 6468 1660 / debora.fiore@huesped.org.ar
"Reproduced with permission - Fundacion Huesped "
Fundacion Huesped
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