Correction: The Effect of Raltegravir Intensification on Low-level Residual Viremia in HIV-Infected Patients on Antiretroviral Therapy: A Randomized Controlled Trial
Year: 2011
Type: erratum
Abstract: Background: Most HIV-1-infected patients on effective antiretroviral therapy (ART) with plasma HIV-1 RNA levels below the detection limits of commercial assays have residual viremia measurable by more sensitive methods.We assessed whether adding raltegravir lowered the level of residual viremia in such patients. Methods and Findings:Patients receiving ART who had plasma HIV-1 RNA levels below 50 copies/mL but detectable viremia by single copy assay (SCA) were randomized to add either raltegravir or placebo to their ART regimen for 12 weeks; patients then crossed-over to the other therapy for an additional 12 weeks while continuing pre-study ART.The primary endpoint was the plasma HIV-1 RNA by SCA averaged between weeks 10 and 12 (10/12) compared between treatment groups.Fifty-three patients were enrolled.The median screening HIV-1 RNA was 1.7 copies/mL.The HIV-1 RNA level at weeks 10/12 did not differ significantly between the raltegravir-intensified (n = 25) and the placebo (n = 24) groups (median 1.2 versus 1.7 copies/mL, p = 0.55, Wilcoxon rank sum test), nor did the change in HIV-1 RNA level from baseline to week 10/12 (median 20.2 and 20.1 copies/mL, p = 0.71, Wilcoxon rank sum test).There was also no significant change in HIV-1 RNA level from weeks 10/12 to weeks 22/24 after patients crossed-over.There was a greater CD4 cell count increase from baseline to week 12 in the raltegravir-intensified group compared with the placebo group (+42 versus 244 cells/mm 3 , p = 0.082, Wilcoxon rank sum test), which reversed after the cross-over.This CD4 cell count change was not associated with an effect of raltegravir intensification on markers of CD4 or CD8 cell activation in blood. Conclusion:In this randomized, double-blind cross-over study, 12 weeks of raltegravir intensification did not demonstrably reduce low-level plasma viremia in patients on currently recommended ART.This finding suggests that residual viremia does not arise from ongoing cycles of HIV-1 replication and infection of new cells.New therapeutic strategies to eliminate reservoirs that produce residual viremia will be required to eradicate HIV-1 infection.
Source: PLoS Medicine
Institutions: Ragon Institute of MGH, MIT and Harvard, Massachusetts General Hospital, Harvard University, University of North Carolina at Chapel Hill, National Institute of Allergy and Infectious Diseases, Social and Scientific Systems (United States), Karolinska Institutet, Case Western Reserve University, Beth Israel Deaconess Medical Center, Drexel University, Frederick National Laboratory for Cancer Research, National Cancer Institute, Tufts University, University of Pittsburgh
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $6,460
OpenAlex ID: W4234668722
