Research Article: The Effect of Raltegravir Intensification on Low-level Residual Viremia in HIV-Infected Patients on Antiretroviral Therapy: A Randomized Controlled Trial

Date Published: August 10, 2010

Publisher: Public Library of Science

Author(s): Rajesh T. Gandhi, Lu Zheng, Ronald J. Bosch, Ellen S. Chan, David M. Margolis, Sarah Read, Beatrice Kallungal, Sarah Palmer, Kathy Medvik, Michael M. Lederman, Nadia Alatrakchi, Jeffrey M. Jacobson, Ann Wiegand, Mary Kearney, John M. Coffin, John W. Mellors, Joseph J. Eron

Abstract: In a double-blind trial, Rajesh Gandhi and colleagues detect no significant reduction in viral load after people with low-level HIV viremia added an integrase inhibitor to their treatment regimen.

Partial Text: Although currently recommended antiretroviral therapy (ART) lowers plasma HIV-1 RNA levels to below the detection limit of commercial assays (generally <50 copies/mL), most patients have persistent low-level viremia when tested with more sensitive methods [1]. In fact, using a real-time PCR assay that detects a single copy of HIV-1 RNA, more than 80% of patients on combination ART had viremia of one copy/mL or more [2]. This residual viremia does not measurably decay after up to 7 years of ART [3]. This study was conducted according to the principles expressed in the Declaration of Helsinki. The study (Text S1 and S2) was approved by the Institutional Review Boards of all institutions at which patients were enrolled. All patients provided written informed consent for study participation, the collection of samples and subsequent analysis. The NCT number for this study is NCT00515827. In this randomized, double-blind, placebo-controlled cross-over study, 12 weeks of raltegravir intensification did not demonstrably reduce residual viremia in patients on PI- or NNRTI-containing ART. Although there was a trend toward an increased CD4 cell count during the period of raltegravir intensification, this change was not associated with an effect of raltegravir on T cell activation. CD4 and CD8 cell activation levels in blood, as determined by the percentage of CD38+/HLA-DR+ cells, were not associated with the baseline level of residual viremia, and we did not find evidence that raltegravir intensification reduced T cell activation by this measure. Source:


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