Safety and acceptability of the candidate microbicide Carraguard in Thai women: Findings from a phase II clinical trial
Safety and acceptability of the candidate microbicide Carraguard in Thai women: Findings from a phase II clinical trial
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DOI：
10.1097/01.qai.0000243056.59860.c1
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发表时间：
2006-11-01
影响因子：
3.6
通讯作者：
Mastro, Timothy D.
中科院分区：
文献类型：
--
作者：
Kilmarx, Peter H.;van de Wijgert, Janneke H. H. M.;Mastro, Timothy D.
目的：确定 Carraguard（一种源自角叉菜胶的候选杀菌剂凝胶）阴道使用的安全性和可接受性。设计：在泰国北部清莱进行了一项随机、安慰剂对照、三盲临床试验。方法：要求女性每周至少 3 次（有或没有性行为）将研究凝胶插入阴道，每次使用凝胶时均使用避孕套 他们发生了性关系。通过目视检查阴道和子宫颈、第 14 天、第 I 个月以及随后每月一次的阴道菌群变化和自我报告症状来评估安全性，直至 I 年。通过报告凝胶的使用情况、使用过和未使用的涂抹器的归还以及季度访谈来评估可接受性。结果：165 名女性被随机分配：83 人分配到 Carraguard 组，82 人分配到安慰剂（甲基纤维素凝胶）组。在整个试验过程中，两组研究凝胶的使用量相似，平均每周使用四个涂抹器。 Carraguard的使用与异常生殖器临床表现、异常阴道菌群、巴氏涂片异常或其他异常临床体征或症状无关。不良事件大多是轻微的，与凝胶的使用无关，并且在各组之间的分布相似。两组参与者都报告了较高的可接受性。结论：无论有无性行为，Carraguard 平均每周可以安全使用四次，并且对于泰国女性来说是可以接受的。 Carraguard 的 III 期疗效试验是必要的，目前正在南非进行。
Objective: To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel.Design: A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand.Methods: Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month I and then monthly for up to I year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews.Results: One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (metbyleellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability.Conclusions: Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.