Advances in the Development of Microbicides for the Prevention of HIV Infection.
Advances in the Development of Microbicides for the Prevention of HIV Infection.
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DOI：
10.1007/s11908-009-0076-5
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发表时间：
2010-01-01
影响因子：
3.1
通讯作者：
McGowan, Ian
中科院分区：
文献类型：
--
作者：
Minces, Lucio R;McGowan, Ian
杀微生物剂是可以应用于阴道或直肠粘膜的产品，目的是预防或至少显着减少性传播感染（包括HIV-1）的传播。过去2 - 3年的杀微生物剂研究产生了一些令人失望的结果。大型2B/3期研究未能证明产品有效性，因无效而提前停止，在最坏情况下可能证明杀微生物剂诱导的伤害。最近完成的疗效研究（HPTN-035）未达到统计学显著性，但确实显示使用PRO-2000与HIV感染减少30%相关。目前的研究集中在更有效的靶向治疗，包括逆转录酶抑制剂和CCR 5拮抗剂。持续的挑战包括优化1/2期研究中安全性信号的识别，定义将产品推进疗效研究的理由，以及为这些研究识别具有足够HIV血清发生率的人群。
Microbicides are products that can be applied to vaginal or rectal mucosa with the intent of preventing, or at least significantly reducing, the transmission of sexually transmitted infections, including HIV-1. The past 2 or 3 years of microbicide research have generated several disappointments. Large, phase 2B/3 studies failed to demonstrate product efficacy, were stopped prematurely for futility, and in the worst-case scenario possibly demonstrated microbicide-induced harm. The most recently completed efficacy study (HPTN-035) did not reach statistical significance, but did show that use of PRO-2000 was associated with a 30% reduction in HIV acquisition. Current research focuses on much more potent targeted therapy, including reverse transcriptase inhibitors and CCR5 antagonists. Ongoing challenges include optimizing the identification of safety signals in phase 1/2 studies, defining a rationale for advancing products into efficacy studies, and identifying populations with adequate HIV seroincidence rates for these studies.