Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
PLoS One. 2013 Jul 16;8(7):e68286. doi: 10.1371/journal.pone.0068286. Print 2013.
Data regarding the efficacy of directly administered antiretroviral therapy (DAART) are mixed. Opioid treatment programs (OTPs) provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT) among HIV-infected subjects attending five OTPs in Baltimore, MD.
HIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART) or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA <50 copies/mL during the intervention phase (3-, 6-, and 12-month study visits), using a logistic regression model accounting for intra-person correlation due to repeated observations. Adherence was measured with electronic monitors in both arms.
We randomized 55 and 52 subjects from five Baltimore OTPs to DAART and SAT, respectively. The average proportions with HIV RNA <50 copies/mL during the intervention phase were 0.51 in DAART and 0.40 in SAT (difference 0.11, 95% CI: -0.020 to 0.24). There were no significant differences between arms in electronically-measured adherence, average CD4 cell increase from baseline, average change in log10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.
In this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.
ClinicalTrials.gov NCT00279110 NCT00279110?term = NCT00279110&rank = 1.
直接给予抗逆转录病毒治疗（DAART）的疗效数据参差不齐。阿片类药物治疗计划（OTP）为 DAART 提供了一个便利的框架。在马里兰州巴尔的摩的五家 OTP 中，我们对接受治疗的 HIV 感染者进行了一项随机对照试验，比较了 DAART 和自我管理治疗（SAT）。
如果参加 OTP 的 HIV 感染者未接受抗逆转录病毒治疗（ART）或在上一次临床评估时病毒学上对 ART 治疗失败，则有资格参加。在接受 DAART 的受试者中，我们在 OTP 观察每个工作日接受一次 ART 剂量，最多 12 个月。SAT 受试者在家中管理 ART。主要疗效比较是干预阶段中 HIV RNA <50 拷贝/ml 的平均比例在两组之间的差异（3、6 和 12 个月的研究访视），使用考虑到由于重复观察而导致的个体内相关性的逻辑回归模型。在这两个臂中均使用电子监测器测量依从性。
我们从巴尔的摩的五家 OTP 随机分配了 55 名和 52 名受试者分别接受 DAART 和 SAT。干预阶段中 HIV RNA <50 拷贝/ml 的平均比例分别为 DAART 组的 0.51 和 SAT 组的 0.40（差异为 0.11，95%CI：-0.020 至 0.24）。在电子监测测量的依从性、从基线开始的平均 CD4 细胞增加、从基线开始的 HIV RNA 对数 10 的平均变化、机会性疾病、住院、死亡率或新耐药突变的发展方面，两组之间没有显著差异。
在这项随机试验中，我们发现 DAART 与 OTP 中接受治疗的 HIV 感染者的 SAT 相比，几乎没有提供临床益处的证据。
ClinicalTrials.gov NCT00279110 NCT00279110?term = NCT00279110&rank = 1.
