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首页> 外文期刊>AIDS care. >A randomised control trial of structured interrupted generic antiretroviral therapy versus continuous therapy in HIV-infected individuals in Southern India.
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A randomised control trial of structured interrupted generic antiretroviral therapy versus continuous therapy in HIV-infected individuals in Southern India.

机译：在印度南部感染艾滋病毒的个体中，进行结构化中药抗逆转录病毒常规治疗与连续治疗的随机对照试验。

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This randomised control trial, conducted in Chennai, India, compared structured interrupted therapy (SIT) and continuous therapy (CT) in relation to immunologic and virologic outcomes, adverse events (AEs) and cost of therapy. ART-naive adult HIV1-infected participants with CD4 counts 50-350 cells/mm(3), and plasma viral load (PVL)>5000 copies/mL were enrolled and placed on Indian-manufactured generic ART: zidovudine(AZT)/stavudine(d4T)+lamivudine(3TC)+efavirenz(EFV). After at least six months of continuous therapy, subjects were randomised to SIT (one-week-on/one-week-off cycles) or CT. The primary end-point was the proportion of subjects maintaining CD4>200 cells/mm(3) at six and 12 months after randomisation. Secondary end-points were effective viral suppression (PVL<400 copies/mL), AEs and cost. All analyses used intention-to-treat methodology. Of 40 participants (69% male; mean age 36+/-7; median baseline CD4 and PVL: 162 cell/mm(3)and 259,000 copies/mL), 17 were randomised to SIT and 18 to CT. Atrandomisation, median CD4s for SIT and CT were 378 cells/mm(3) and 357 cells/mm(3), respectively. All participants had PVL<400 copies/mL at time of randomisation. Median CD4 six months after randomisation was 498 cells/mm(3) and 417 cells/mm(3) for SIT and CT respectively. All participants had CD4>200 cells/mm(3). One participant on CT and two on SIT had sustained PVL>400 copies/mL. There were no serious AEs or deaths. Structured interrupted therapy cost was half of CT. Structured interrupted therapy was effective at maintaining CD4 above 200 cells/mm(3). Adverse events were comparable in both groups, with 50% reduction in cost for SIT. Further research on such strategies may benefit resource-constrained settings.
机译：这项在印度钦奈进行的随机对照试验比较了结构性中断治疗（SIT）和连续治疗（CT）的免疫学和病毒学结果，不良事件（AEs）和治疗费用。初次接受ART的成年HIV1感染参与者的CD4计数为50-350细胞/ mm（3），血浆病毒载量（PVL）> 5000拷贝/ mL，并将其置于印度生产的通用ART上：齐多夫定（AZT）/司他夫定（d4T）+拉米夫定（3TC）+依非韦伦（EFV）。连续治疗至少六个月后，将受试者随机分为SIT（每周一次/每周一次）或CT。主要终点是受试者在随机分组后六个月和十二个月保持CD4> 200细胞/ mm（3）的比例。次要终点是有效的病毒抑制（PVL <400拷贝/ mL），不良事件和成本。所有分析均采用意向性治疗方法。在40名参与者（69％男性;平均年龄36 +/- 7;基线CD4和PVL中位数：162细胞/ mm（3）和259,000拷贝/ mL）中，有17名被随机分配到SIT，18名被随机分配到CT。随机性，SIT和CT的中值CD4s分别为378细胞/ mm（3）和357细胞/ mm（3）。随机分组时，所有参与者的PVL <400拷贝/ mL。随机化六个月后，SIT和CT的中位CD4分别为498细胞/ mm（3）和417细胞/ mm（3）。所有参与者的CD4> 200细胞/ mm（3）。一名CT参与者和两名SIT参与者的PVL持续> 400拷贝/ mL。没有严重的不良事件或死亡。结构性中断治疗费用为CT的一半。结构性中断治疗有效维持CD4高于200细胞/ mm（3）。两组的不良事件相当，SIT成本降低了50％。对此类策略的进一步研究可能会使资源有限的环境受益。

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