A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4⁺ T-cell recovery despite sustained virologic suppression: ACTG A5256

Background. Despite viral suppression, antiretroviral therapy (ART) does not restore CD4⁺ T-cell counts in many patients infected with human immunodeficiency virus type 1 (HIV-1). Methods. In a single-arm pilot trial involving ART recipients with suppressed plasma levels of HIV-1 RNA for at least 48 weeks and stable suboptimal CD4⁺ T-cell recovery, subjects added maraviroc, a CCR5 antagonist, to their existing ART for 24 weeks. After stopping maraviroc, they were followed for an additional 24 weeks. A Wilcoxon signed-rank test was used to evaluate whether maraviroc was associated with an increase of at least 20 cells/μL in the CD4⁺ T-cell count. Results. A total of 34 subjects were enrolled. The median age was 50 years, and the median baseline CD4⁺ T-cell count was 153 cells/μL. The median increase in CD4⁺ T-cell count from baseline to week 22/24 was 12 cells/μL (90% confidence interval, 1-22). A CD4⁺ T-cell count increase of at least 20 cells/μL was not detected (P = .97). Markers of immune activation and apoptosis decreased during maraviroc intensification; this decline partially reversed after discontinuing maraviroc. Conclusions. Adding maraviroc to suppressive ART for 24 weeks was not associated with an increase in CD4⁺ T-cell counts of at least 20 cells/μL. Further studies of CCR5 antagonists in the dampening of immune activation associated with HIV infection are warranted.