Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria.
Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria.
复制标题
DOI：
10.1371/journal.pone.0003784
复制
发表时间：
2008
期刊：
影响因子：
3.7
通讯作者：
Abdellati S
中科院分区：
文献类型：
--
作者：
Halpern V;Ogunsola F;Obunge O;Wang CH;Onyejepu N;Oduyebo O;Taylor D;McNeil L;Mehta N;Umo-Otong J;Otusanya S;Crucitti T;Abdellati S
该试验评估了6%硫酸纤维素阴道凝胶在预防HIV、淋病和衣原体感染的男女阴道传播方面的安全性和有效性。这项三期、双盲、随机、安慰剂对照试验于2004年11月至2007年3月在尼日利亚拉各斯和哈科特港进行。我们招募了1644名HIV抗体阴性、HIV感染风险高的妇女。研究参与者以1∶1的比例随机分为硫酸纤维素组和安慰剂组，并在一年的随访中要求每次阴道性交时使用凝胶和避孕套。参与者每月评估HIV，淋病和衣原体感染以及不良事件。在一项平行试验的数据安全监测委员会得出结论，硫酸纤维素可能会增加感染艾滋病毒的风险后，该试验过早停止。相比之下，我们观察到活动组的感染（10例）少于安慰剂组（13例），但差异无统计学意义（HR = 0.8, 95% CI 0.3-1.8; p = 0.56）。淋病和衣原体感染率在CS组较低，但差异同样无统计学意义（HR = 0.8, 95% CI 0.5-1.1；合并STI结果p = 0.19）。各研究组的不良事件发生率相似。未见与使用硫酸纤维素相关的严重不良事件的报道。在评估的研究人群中，硫酸纤维素凝胶似乎是安全的，但我们没有发现足够的证据表明它可以预防HIV、淋病或衣原体感染的男性到女性阴道传播。试验的过早结束损害了得出关于硫酸纤维素抗艾滋病毒有效性的明确结论的能力。ClinicalTrials.gov NCT00120770
This trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection. This Phase III, double-blind, randomized, placebo-controlled trial was conducted between November 2004 and March 2007 in Lagos and Port Harcourt, Nigeria. We enrolled 1644 HIV-antibody negative women at high risk of HIV acquisition. Study participants were randomized 1∶1 to cellulose sulfate or placebo and asked to use gel plus a condom for each act of vaginal intercourse over one year of follow-up. The participants were evaluated monthly for HIV, gonorrhea and chlamydial infection, and for adverse events. The trial was stopped prematurely after the data safety monitoring board of a parallel trial concluded that cellulose sulfate might be increasing the risk of HIV. In contrast, we observed fewer infections in the active arm (10) than on placebo (13), a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3–1.8; p = 0.56). Rates of gonorrhea and chlamydial infection were lower in the CS group but the difference was likewise not statistically significant (HR = 0.8, 95% CI 0.5–1.1; p = 0.19 for the combined STI outcome). Rates of adverse events were similar across study arms. No serious adverse events related to cellulose sulfate use were reported. Cellulose sulfate gel appeared to be safe in the evaluated study population but we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. The early closure of the trial compromised the ability to draw definitive conclusions about the effectiveness of cellulose sulfate against HIV. ClinicalTrials.gov NCT00120770
登录
查看更多内容
影响因子：
168.9
作者：
Padian, Nancy S.;van der Straten, Ariane;McIntyre, James
通讯作者：
McIntyre, James
影响因子：
168.9
作者：
Moher, D;Schulz, KF;Altman, DG
通讯作者：
Altman, DG
影响因子：
158.5
作者：
Van Damme, Lut;Govinden, Roshini;Taylor, Doug
通讯作者：
Taylor, Doug
影响因子：
168.9
作者：
Celum, Connie;Wald, Anna;Corey, Lawrence
通讯作者：
Corey, Lawrence
影响因子：
2.9
作者：
Mauck, C;Frezieres, R;Callahan, M
通讯作者：
Callahan, M