Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004).
Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004).
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DOI：
10.1097/qad.0b013e328346bd3e
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发表时间：
2011-05-15
期刊：
影响因子：
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通讯作者：
MTN-004 Protocol Team
中科院分区：
文献类型：
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作者：
McGowan I;Gomez K;Bruder K;Febo I;Chen BA;Richardson BA;Husnik M;Livant E;Price C;Jacobson C;MTN-004 Protocol Team
本研究旨在评价3%SPL7013凝胶(VivaGel®)的安全性、依从性、可接受性以及对阴道微生物区系的影响。第一阶段，性活跃女性的随机、双盲、安慰剂对照研究。从美国的三个地点招募了61名年龄在18-24岁之间的性活跃女性。参与者以1：1：1的比例随机接受VivaGel、VivaGel安慰剂或羟乙基纤维素(HEC)安慰剂的治疗，连续14天，每天两次。安全终点包括泌尿生殖道和/或其他不良事件(AE)。通过革兰氏染色阴道涂片和定量阴道培养确定阴道菌群的变化。没有严重的不良反应或因不良反应而撤资的报告。泌尿生殖系统症状报告如下：VivaGel(n=17/22；77.3%)、VivaGel安慰剂(n=14/21；66.7%)和HEC(n=8/18；44.4%)(NS，p=0.1)。在研究的所有凝胶组中，盆腔检查异常的发生率是相似的。采用配对比较，使用Viva Gel组的妇女与使用HEC凝胶组的妇女相比，其相关的泌尿生殖系统不良反应的发生率显著更高(分别为每百人年0.297例和0.111例；p=0.003)。暴露于VivaGel和VivaGel安慰剂会导致阴道微生物区系发生轻微变化，但根据纽金特评分评估，这对细菌性阴道病的发病率没有总体影响。VivaGel总体耐受性良好，与VivaGel安慰剂相当，尽管与HEC安慰剂相比，低级别相关生殖器不良反应的发生率更高。
The study was designed to assess the safety, adherence, acceptability, and effect on vaginal microflora of 3% SPL7013 Gel (VivaGel®), a novel dendrimer topical microbicide that inhibits HIV, HSV-2 and HPV in vitro and in animal models. Phase 1, randomized, double-blind, placebo-controlled study in sexually active women. Sixty-one sexually active women aged 18–24 years were recruited from three sites in the United States. Participants were randomized 1:1:1 to receive VivaGel, VivaGel placebo, or a hydroxyethylcellulose (HEC) placebo twice daily for 14 consecutive days. Safety endpoints included genitourinary and/or other adverse events (AE). Changes in vaginal flora were determined from Gram-stained vaginal smears and quantitative vaginal culture. No serious AEs or withdrawals due to AEs were reported. Genitourinary symptoms were reported as follows: VivaGel (n=17/22; 77.3%), VivaGel placebo (n=14/21; 66.7%) and HEC (n=8/18; 44.4%) (NS, p=0.1). The incidence of abnormal pelvic exam findings was similar across all gel arms of the study. Using pair-wise comparison, women in the VivaGel arm had a significantly higher incidence of related genitourinary AEs compared with women in the HEC gel arm (0.297 versus 0.111 per 100 person years, respectively; p=0.003). Exposure to VivaGel and VivaGel placebo resulted in minor shifts in the vaginal microflora but there was no overall impact on incidence of bacterial vaginosis as assessed by Nugent score. VivaGel was generally well tolerated and comparable with the VivaGel placebo, although there was a higher incidence of low grade related genital AEs compared to the HEC placebo gel.