Currier J S, Williams P L, Koletar S L, Cohn S E, Murphy R L, Heald A E, Hafner R, Bassily E L, Lederman H M, Knirsch C, Benson C A, Valdez H, Aberg J A, McCutchan J A
University of California, Los Angeles, CARE Center, 10833 LeConte Avenue, Room BH-412 CHS, Los Angeles, CA 90095, USA.
Ann Intern Med. 2000 Oct 3;133(7):493-503. doi: 10.7326/0003-4819-133-7-200010030-00008.
Patients infected with HIV who experience increases in CD4(+) cell counts are at reduced risk for opportunistic infections. However, the safety of discontinuing prophylaxis against Mycobacterium avium complex has been uncertain.
To compare the rate of M. avium complex infection in patients with increased CD4(+) cell counts who receive azithromycin and those receiving placebo.
Randomized, double-blind, placebo-controlled trial.
29 university-based clinical centers in the United States.
643 HIV-1-infected patients with a previous CD4(+) cell count less than 0.05 x 10(9) cells/L and a sustained increase to greater than 0.10 x 10(9) cells/L during antiretroviral therapy.
Azithromycin, 1200 mg once weekly (n = 321), or matching placebo (n = 322).
Mycobacterium avium complex cultures, CD4(+) cell counts, and clinical evaluations for AIDS-defining illnesses and bacterial infections were done every 8 weeks. Plasma HIV-1 RNA levels were measured at 16-week intervals.
During follow-up (median, 16 months), 2 cases of M. avium complex infection were reported among the 321 patients assigned to placebo (incidence rate, 0.5 event per 100 person-years [95% CI, 0.06 to 1.83 events per 100 person-years]) compared with no cases among the 322 patients assigned to azithromycin (CI, 0 to 0.92 events per 100 person-years), resulting in a treatment difference of 0.5 event per 100 person-years (CI, -0.20 to 1.21 events per 100 person-years) for placebo versus azithromycin. Both cases were atypical in that M. avium complex was localized to the vertebral spine. Patients receiving azithromycin were more likely than those receiving placebo to discontinue treatment with the study drug permanently because of adverse events (8% vs. 2%; hazard ratio, 0.24 [CI, 0.10 to 0.57]).
Prophylaxis against Mycobacterium avium complex can safely be withdrawn or withheld in adults with HIV infection who experience increases in CD4(+) cell count while receiving antiretroviral therapy.
感染人类免疫缺陷病毒（HIV）且CD4(+)细胞计数增加的患者发生机会性感染的风险降低。然而，停止预防鸟分枝杆菌复合体感染的安全性尚不确定。
比较接受阿奇霉素治疗和接受安慰剂治疗的CD4(+)细胞计数增加的患者中鸟分枝杆菌复合体感染的发生率。
随机、双盲、安慰剂对照试验。
美国29个大学附属医院临床中心。
643例HIV-1感染患者，其既往CD4(+)细胞计数低于0.05×10⁹/L，在抗逆转录病毒治疗期间持续增加至高于0.10×10⁹/L。
阿奇霉素，每周一次，每次1200mg（n = 321），或匹配的安慰剂（n = 322）。
每8周进行一次鸟分枝杆菌复合体培养、CD4(+)细胞计数，并对定义艾滋病的疾病和细菌感染进行临床评估。每16周测量一次血浆HIV-1 RNA水平。
在随访期间（中位数为16个月），321例接受安慰剂治疗的患者中有2例报告发生鸟分枝杆菌复合体感染（发病率为每100人年0.5例[95%CI，每100人年0.06至1.83例]），而322例接受阿奇霉素治疗的患者中无感染病例（CI，每100人年0至0.92例），安慰剂组与阿奇霉素组相比，治疗差异为每100人年0.5例（CI，每100人年-0.20至1.21例）。两例均为非典型病例，鸟分枝杆菌复合体局限于脊柱。接受阿奇霉素治疗的患者因不良事件而永久停止使用研究药物的可能性高于接受安慰剂治疗的患者（8%对2%；风险比，0.24[CI，0.10至0.57]）。
对于在接受抗逆转录病毒治疗期间CD4(+)细胞计数增加的成人HIV感染者，可安全停用或暂不使用预防鸟分枝杆菌复合体感染的药物。
