ART success was defined as VL < 400 copies/mL or stable/rising CD4 counts or both. Data on demographics,

adherence, CD4 counts, weights, and post-travel VL were compared between the two groups, between those who had or did not have ART failure and where appropriate before and after travels. t-Test, Wilcoxon-rank-sum (z), Fisher’s exact, and Chi-square (χ2) tests and measures of effect were used for comparison between groups as appropriate, with two-sided p-value < 0.05 regarded as significant. A nested case-controlled analysis was done to determine the role of Hajj in ART failure. Analysis was done using STATA (version 10.0) (College Station, TX, USA). A total of 32 HP on ART performed the Hajj in 2008 to 2009 whereas Ku-0059436 mw 32 NP patients NU7441 in vivo were recruited in the study. One participant each among HP and NP had both high pre-travel and post-travel VL (> 400 copies/mL) and were excluded from analyses. Eventually, 31 HP and 27 NP had the required data and their characteristics are presented in Table 1. The HP spent [median (range)] 36 days (28–43 days) whereas the NP spent 84 days (28–84 days) away before their follow-up appointments (Wilcoxon-rank-sum, z = − 4.09; p < 0.0001). The two groups were broadly on similar three-drug ART regimens. They were on two-drug back bone regimens of Zidovudine/Lamivudine (30), Stavudine/Lamivudine (15) and Tenofovir/Emtricitabine,

or Lamivudine (13) coupled with a non-nucleoside reverse transcriptase inhibitor (NNRTI), either Nevirapine (47) or Efavirenz (7), or the ritonavir-boosted Protease Inhibitor Lopinavir–ritonavir (4); all the latter four were HP patients. The daily dosing frequencies were similar between the two groups with majority on twice daily regimens 27/31 (87%) and 27/27 (100%), respectively (Fisher’s exact; p-value = 0.116). The risk ratio (RR) (95% confidence interval [CI]) of missing at least one ART dose among HP compared with NP in the month preceding their journey was BCKDHA 2.18 (0.46–10.33)

(Table 1). The proportion who missed at least one ART dose among HP and NP while away was 16/31 (51.6%) and 5/27 (18.5%), respectively with RR (95% CI) 2.79 (1.18–6.60). Among HP, the proportion who missed at least one dose during Hajj (16/31 [51.6%]) compared with the month before (5/31 [16.1%]) was with a significantly higher RR (95% CI) 3.20 (1.34–7.65). In addition, the proportion among HP who missed a dose after returning from HP was 9.7%, significantly lower than the proportion who missed a dose during the Hajj (p = 0.0003). In contrast, there was no statistical difference in these proportions among the NP before, during, and after travels. Of the 16 HP who missed a dose during Hajj, 14 did not take ART for a median of 34.5 days (range 1–50 days). Five patients were unable or were not allowed passage with ART medications at airports of departure (1) and arrival (4); all discarded their ART supplies.