A randomized, controlled study evaluating an ...

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Objectives: The aim of the study was to compare the efficacy and safety of induction with the addition of enfuvirtide to a newly designed oral, highly active ...
Journal of Antimicrobial Chemotherapy (2008) 62, 1374– 1378 doi:10.1093/jac/dkn377 Advance Access publication 8 September 2008

A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study Bonaventura Clotet1*, Amedeo Capetti2, Luis E. Soto-Ramirez3, Jose M. Gatell4, Lucy Rowell5, Miklos Salgo6 and Jonathan M. Schapiro7 1

Received 27 May 2008; returned 28 June 2008; revised 31 July 2008; accepted 10 August 2008 Objectives: The aim of the study was to compare the efficacy and safety of induction with the addition of enfuvirtide to a newly designed oral, highly active antiretroviral therapy (HAART) regimen versus HAART alone followed by a maintenance phase wherein participants were randomized to either continue/discontinue enfuvirtide while maintaining HAART or continue HAART alone (NCT00487188). Methods: Participants with HIV-1 RNA 1000 copies/mL, CD4 count 200 cells/mm3 and genotype sensitivity score 2 (excluding enfuvirtide) were randomized 2:1 to enfuvirtide1HAART or HAART alone and assessed every 4 weeks. Participants achieving

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