Study drug adherence and loss to follow-up.

<p><b>A, B</b>: Study drug adherence calculated from pill counts of returned, unused study medication in female (A) and male (B) study participants. P-values were calculated by 2way ANOVA <b>C</b>: Loss to follow-up during the two-year study. P value was calculated by log-rank (Mantel-Cox) analysis.</p

Study participants at risk.

<p>Number of study participants at risk within the intent-to-treat (ITT) population (<b>A</b>) or the per protocol (PP) population (<b>B</b>). Separate analyses for female study participants (C, D) and for male study participants (E, F).</p

Effects of prednisolone on CD4 counts and CD4/CD8 ratio.

<p><b>A</b>: Mean CD4 ± S.D. P-values were determined by 2way ANOVA. <b>B</b>: Mean CD4 changes ± S.D. relative to baseline and linear regression of the data. 2-year gains/losses were calculated from slope of linear regression. <b>C</b>: Mean ± S.D. CD4/CD8-ratio and linear regression. B, C: P values on the right indicate non-zero hypotheses for the slope. P-value on the left for difference between the two data sets was calculated by 2way ANOVA. <b>D-F</b> and <b>G-I</b>: Post-hoc analyses for female study participants (D-F) and for male study participants (H-I) for absolute CD4 counts (D, G), CD4 relative CD4 changes (E, H), and CD4/CD8 ratio (F, I).</p

Progression to HAART as treated.

<p>Kaplan-Meyer estimate of progression to HAART as treated within the intent-to-treat (ITT) population (<b>A</b>) or the per protocol (PP) population (<b>B</b>). Separate analyses for female study participants (B, E) and for male study participants (C, F) for progression to HART as treated. P values were calculated by log-rank (Mantel-Cox) analysis.</p

Effects of prednisolone on HIV disease progression: Primary Study Endpoint.

<p>Kaplan-Meyer estimate of progression to combined study endpoint (onset of CDC stage-C-condition or drop of CD4 counts below 200) within the intent-to-treat (ITT) population (<b>A</b>) or the per protocol (PP) population (<b>B</b>). <b>C</b>: Progression to AIDS-defining condition. All study participants who received HAART, but did not reach the study endpoint were censored for the KM analysis. <b>D-F</b> and <b>G-I</b>: Post-hoc analyses for female study participants (D-F) and for male study participants (H-I) for progression to combined endpoint within the ITT population (D, G), progression to combined endpoint within the PP population (E, H), and progression to AIDS-defining condition (F, I). A-I: P values were calculated by log-rank (Mantel-Cox) analysis.</p

CONSORT statement 2010 flow diagram.

<p>The number of participants enrolled, randomized, allocated to study medication, followed-up and analyzed is shown. Study participants who progressed to the endpoint of the study (CD4 < 200 or CDC stage-C disease) received HAART. In some cases, study participants also received HAART when they progressed to CD4 < 350 in combination with WHO stage 3-disease. This was in accordance to the National Tanzanian treatment recommendations Update in 2008 (1 case in the placebo arm and 3 cases in the prednisolone arm). In addition, one patient in the placebo arm and 2 study participants in the prednisolone arm received HAART without fulfilling either the study endpoint or the criteria listed in the National Treatment recommendation update.</p

CD4 counts of study participants with loss of follow-up.

<p><b>A:</b> Baseline (BL) CD4 counts from study participants who were later lost to follow up (lost) and who fulfilled (fulfilled) the study. P value was calculated by Mann-Whitney test. <b>B:</b> CD4 counts prior to loss to follow up (loss) or to progression to the primary endpoint (HAART). Red bars (placebo) and blue bars (prednisolone) represent medians. P values were calculated by Kruskal-Wallis test with multiple comparisons.</p

Effects of prednisolone on immune activation and HIV viral load.

<p><b>A, E, I:</b> Concentration of sCD14 was determined by ELISA from n = 134 (placebo) and n = 136 (prednisolone) available plasma samples collected at baseline, 3, 6 and 12 months. A: all sexes, E: females (n_Plac = 106, n_Pred = 110), I: males (n_Plac = 28, n_Pred = 26). <b>B, F, J:</b> Concentration of sUPAR was determined by ELISA from n = 122 (placebo) and n = 124 (prednisolone) available plasma samples collected at baseline, 3, 6 and 12 months. B: all sexes, F: females (n_Plac = 95, n_Pred = 102), J: males (n_Plac = 27, n_Pred = 22). A, B, E, F, I, J: Data as means ± S.D. P-values were determined by 2-way ANOVA (difference between the two treatments over the whole time period) or by Wilcoxon matched-pairs signed test (changes between Baseline and month 12). <b>C, G, K:</b> CD38/HLA-DR expression was determined by flow cytometry from n = 22 (placebo) and n = 30 (prednisolone) available frozen PBMC samples collected at baseline and 12 months. C: all sexes, G: females (n_Plac = 19, n_Pred = 27), K: males (n_Plac = 3, n_Pred = 3). P-values were determined by Wilcoxon matched-pairs signed test (changes between Baseline and month 12). <b>D, H, L:</b> HIV viral load was determined from n = 86 (placebo) and n = 80 (prednisolone) available plasma pairs at baseline and month 12. D: all sexes, H: females (n_Plac = 70, n_Pred = 66), L: males (n_Plac = 16, n_Pred = 14). P-values were determined by Wilcoxon matched-pairs signed test (changes between Baseline and month 12) and by Mann-Whitney test (comparison of month 12 placebo versus month 12 prednisolone).</p