SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria.
SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria.
复制标题
DOI：
10.1371/journal.pone.0001474
复制
发表时间：
2008-01-23
期刊：
影响因子：
3.7
通讯作者：
Rountree W
中科院分区：
文献类型：
--
作者：
Feldblum PJ;Adeiga A;Bakare R;Wevill S;Lendvay A;Obadaki F;Olayemi MO;Wang L;Nanda K;Rountree W
本试验的目的是确定1.0%C31G（SAVVY）在高危女性中预防HIV感染的男性到女性阴道传播的有效性。这是一项III期、双盲、随机、安慰剂对照试验。参与者每月进行12次随访，以进行HIV检测、不良事件报告和研究产品供应。该研究于2004年9月至2006年12月在尼日利亚的拉各斯和伊巴丹进行，在那里我们招募了2153名HIV感染高危的HIV阴性女性。受试者按1∶1的比例随机分配至SAVVY组或安慰剂组。有效性终点是通过检测口腔粘膜渗出液（快速检测）或血液（ELISA）中的HIV抗体指示的HIV感染发生率，并通过蛋白质印迹或PCR检测证实。我们观察到33例血清转换（SAVVY组21例，安慰剂组12例）。SAVVY组和安慰剂组12个月时HIV感染累积概率的Kaplan-Meier估计值分别为0.028和0.015（治疗效应对数秩检验的双侧p值为0.121）。SAVVY组与安慰剂组风险比的点估计值为1.7（95%置信区间0.9，3.5）。由于低于预期的HIV感染率，我们没有观察到足够的把握度来检测SAVVY效应所需的HIV感染人数（66）。研究组中不良事件、生殖道不良事件、异常盆腔检查结果、衣原体感染和阴道感染的随访频率相似。没有严重不良事件可归因于SAVVY的使用。SAVVY并没有降低艾滋病毒感染率。尽管SAVVY组的风险比高于安慰剂组，但我们不能得出SAVVY有有害治疗效应的结论。ClinicalTrials.gov NCT00130078
The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk. This was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly follow-up visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between September 2004 and December 2006 in Lagos and Ibadan, Nigeria, where we enrolled 2153 HIV-negative women at high risk of HIV infection. Participants were randomized 1∶1 to SAVVY or placebo. The effectiveness endpoint was incidence of HIV infection as indicated by detection of HIV antibodies in oral mucosal transudate (rapid test) or blood (ELISA), and confirmed by Western blot or PCR testing. We observed 33 seroconversions (21 in the SAVVY group, 12 in the placebo group). The Kaplan-Meier estimates of the cumulative probability of HIV infection at 12 months were 0.028 in the SAVVY group and 0.015 in the placebo group (2-sided p-value for the log-rank test of treatment effect 0.121). The point estimate of the hazard ratio was 1.7 for SAVVY versus placebo (95% confidence interval 0.9, 3.5). Because of lower-than-expected HIV incidence, we did not observe the required number of HIV infections (66) for adequate power to detect an effect of SAVVY. Follow-up frequencies of adverse events, reproductive tract adverse events, abnormal pelvic examination findings, chlamydial infections and vaginal infections were similar in the study arms. No serious adverse event was attributable to SAVVY use. SAVVY did not reduce the incidence of HIV infection. Although the hazard ratio was higher in the SAVVY than the placebo group, we cannot conclude that there was a harmful treatment effect of SAVVY. ClinicalTrials.gov NCT00130078
登录
查看更多内容
影响因子：
2.9
作者：
Mauck, CK;Frezieres, RG;Bax, R
通讯作者：
Bax, R
影响因子：
168.9
作者：
Moher, D;Schulz, KF;Altman, DG
通讯作者：
Altman, DG
影响因子：
4.9
作者：
Krebs, FC;Miller, SR;Wigdahl, B
通讯作者：
Wigdahl, B
影响因子：
1.9
作者：
OBRIEN, PC;FLEMING, TR
通讯作者：
FLEMING, TR
影响因子：
2.9
作者：
Ballagh, SA;Baker, JM;Archer, DF
通讯作者：
Archer, DF