Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
Int J Tuberc Lung Dis. 2012 Apr;16(4):473-9. doi: 10.5588/ijtld.11.0548.
Two international, multicenter Phase 2 clinical trials examining fluoroquinolone-containing regimens in adults with smear-positive pulmonary tuberculosis (TB), conducted from July 2003 to March 2007. Both trials enrolled human immunodeficiency virus (HIV) infected participants who were not receiving antiretroviral therapy (ART) at TB treatment initiation.
To assess the impact of HIV infection on TB treatment outcomes in Phase 2 clinical trials.
Cross-protocol analysis comparing the safety, tolerability and outcomes of anti-tuberculosis treatment by HIV status.
Of 750 participants who received at least one dose of study treatment, 123 (16%) were HIV-infected. Treatment completion rates were similar by HIV status (81% infected vs. 85% non-infected), as were rates of week 8 culture conversion (66% infected vs. 63% non-infected), and treatment failure (5% infected vs. 3% non-infected). Among HIV-infected participants, treatment failure detected using liquid media was more frequent in those treated thrice weekly (14% thrice weekly vs. 2% daily, P = 0.03). HIV-infected participants more frequently experienced an adverse event during the intensive phase treatment than non-HIV-infected participants (30% vs. 15%, P < 0.01).
HIV-infected persons not receiving ART had more adverse events during the intensive phase of anti-tuberculosis treatment, but tolerated treatment well. Failure rates were higher among HIV-infected persons treated with thrice-weekly intensive phase therapy.
两项针对成人涂阳肺结核（TB）的国际多中心 2 期临床试验，于 2003 年 7 月至 2007 年 3 月进行，均纳入未在 TB 治疗开始时接受抗逆转录病毒治疗（ART）的人类免疫缺陷病毒（HIV）感染者。
评估 HIV 感染对 2 期临床试验中 TB 治疗结局的影响。
对 HIV 状态下抗结核治疗的安全性、耐受性和结局进行跨方案分析。
在接受至少一剂研究治疗的 750 名参与者中，123 名（16%）为 HIV 感染者。HIV 感染者的治疗完成率与非感染者相似（81% vs. 85%），8 周时培养物转化率（66% vs. 63%）和治疗失败率（5% vs. 3%）也相似。在 HIV 感染者中，每周 3 次治疗的治疗失败率高于每日治疗（14% vs. 2%，P = 0.03）。与非 HIV 感染者相比，HIV 感染者在强化期治疗期间更常发生不良事件（30% vs. 15%，P < 0.01）。
未接受 ART 的 HIV 感染者在强化期抗结核治疗期间发生更多不良事件，但能很好地耐受治疗。每周 3 次强化期治疗的 HIV 感染者失败率更高。
