he primary endpoints and was defined as the mean of the ATI weeks 12 and 16 pVL. After ATI week 16, study participants had the option of resuming ART or continuing the treatment interruption. Resumption of ART was recommended under any of the following conditions: confirmed CD4+ cell count,300/mm3, three consecutive HIV-1 RNA levels 300,000 copies/mL, AIDS-defining illness, or development of retroviral rebound syndrome, clinically significant Immunosuppression, based on subject’s clinician preference, or pregnancy. Participants with an HIV-1 set point of,3.0 log10 copies/ml soon after ATI were categorized as early virologic suppressors. This level of plasma viremia has been used to define virologic suppression on ART and transient episodes of low-level viremia . Each individual’s time on ART was calculated as the interval between the date of first ART initiation and date of treatment interruption. Results Characteristics of Initial Virologic Suppressors Of the 104 participants with evaluable pVL set point, 11 were found to have a pVL set point,3.0 log10 copies/ml and were categorized as an initial virologic suppressors. Eighty-two percent of initial virologic suppressors received the vaccine as compared to 66% of the non-suppressors. Initial virologic suppressors had a median pVL set point of 2.6 log10 RNA copies/ml versus a pVL set point of 4.2 log10 RNA copies/ml for virologic non-suppressors. The time on ART and distribution of HLA allele groups was not significantly different between the initial virologic Viral Suppression after Therapeutic Vaccination Variable Overall Initial virologic suppressors Initial nonsuppressors P-valuesa Age, median, years Male, % of subjects Treatment arm, % of subjects Vaccine Placebo Race, % of subjects White Black Hispanic.1 race Asian, Pacific Islander Baseline CD4+ cell count, median, cells/mm3 Pre-ART HIV-1 RNA, median, copies/mL HLA group, % of subjects b Protective Neutral Unfavorable Time on ART, median, yrs ART Regimen, % of subjects c NNRTI, no PI PI, no NNRTI PI and NNRTI Other 50 34 5 11 35 59 6 6.2 69 9 16 1 5 817 4.7 67 33 42 95 40 100 ” 42 95 0.18 1.00 0.50 82 18 66 34 0.59 73 18 9 0 0 825 8663121 3.9 69 8 17 1 5 816 4.8 0.96 0.07 0.56 27 64 9 6.8 36 59 5 6.2 0.59 55 18 0 27 49 36 5 10 0.30 Data are percent of patients unless otherwise indicated. P-values compare the distribution of baseline characteristics between initial virologic suppressors and non-suppressors. For continuous variable, Wilcoxon rank sum test was used, for categorical variable, Fisher’s exact test was use. All the p-values are exact 2-sided p-values. b HLA type defined based on the presence of protective HLA alleles, unfavorable, or neutral HLA alleles. c Antiretroviral regimen at the time of study entry. doi:10.1371/journal.pone.0034134.t001 a suppressor and non-suppressor groups. When compared to CD4+ cell counts at study entry, participants with initial virologic suppression had a median gain of 7 CD4+ cells/mm3 at ATI week 16. This was in 518303-20-3 contrast to a median loss of 247 CD4+ cells/mm3 among non-suppressors. Virologic Factors Associated with Initial Virologic Suppression Of those with available pre-ART pVL data, individuals with initial virologic suppression had lower pre-ART pVL, but this difference was of marginal statistical significance. In addition, those with initial virologic suppression had a significantly greater decrease between pre-ART pVL and the set point pVL compared to those without initial virologic suppressio
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