Male Microbicide Safety, Acceptance & Efficacy Against STI

男性杀菌剂安全性、接受度

• 批准号: 6866160
• 负责人: KING K. HOLMES
• 金额: $ 25.62万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6866160
• 关键词: Africa; African; antiinfective agents; attitude; clinical trial phase I; clinical trial phase II; clinical trial phase III; communicable disease control; cooperative study; disease /disorder etiology; drug screening /evaluation; epidemiology; ethanol; focus groups; herpes simplex virus 2; high risk behavior /lifestyle; human immunodeficiency virus; human subject; human therapy evaluation; interview; male; microorganism disease chemotherapy; patient oriented research; questionnaires; sex behavior; sexually transmitted diseases; therapy compliance; topical drug application

While topical microbicides have a long history of use for prophylaxis against STIs in men, dating back to World Wars I and II, no subsequent clinical trials have examined the efficacy of topical microbicides used on the external genitalia of men to prevent transmission and/or acquisition of STIs, including HIV infection. We plan to (1) assess male genital hygiene, sexual practices, and attitudes about potential topical microbicide use for STI prevention in a fishing community in Kisumu, Kenya where the frequent casual and commercial sex activity of men while away from home place them at high risk for STD/HIV; (2) conduct a randomized Idouble-blinded placebo-controlled crossover Phase 1 trial of the safety, acceptability, and frequency of use Iof a topical microbicide containing 62% ethanol in emollient gel among 30 uncircumcised men over a 6-week Period; and (3) conduct a Phase 2/3 randomized double-blinded placebo-controlled trial among 1030 men to further test the safety of this microbicide and determine its efficacy in reducing the incidence of selected STIs in men using the microbicide over a follow-up period of 1-2 years (average of 21 months). For aim 1, we plan a combination of quantitative and qualitative data collection methods including focus group discussions, in-depth open-ended key informant interviews, and structured interviews to guide development of community support, recruitment and achieving adherence to intervention protocols. The Phase 1 trial will compare safety and acceptability of repeated microbicide use. The Phase 2/3 trial will further assess the safety and the efficacy of this microbicide among men to reduce the incidence of acquired infections with pathogens known or very likely to be highly ethanol-sensitive, including the enveloped viruses HSV-2 and HIV, and the bacterial pathogens which infect the epidermis of the penis, causing genital ulcer disease. The 62% ethanol-emollient gel formulation is very rapidly microbicidal, inexpensive and well-tolerated on hands, commercially available, widely used in health care settings for antisepsis on hands, and available over-the-counter for domestic use in the US. In a stepwise series of studies in Kenyan men, we have obtained preliminary data on the safety and acceptability of this product for topical use on the penis, and are currently evaluating the effects of regular use of this product by men on the vaginal flora of their female partners.

虽然局部微生物在男性中具有较长的预防性使用史，但可以追溯到第一次世界大战和II，但随后的临床试验尚未检查局部生殖器对男性外部生殖器的疗效，以防止包括HIV感染在内的STIS的传播和/或获得性传播和/或获得。我们计划（1）评估男性生殖器卫生，性习俗，以及对肯尼亚基苏木捕鱼社区潜在的局部杀菌剂使用的态度，在那里，男人经常出门的随意和商业性行为，而远离家乡则将他们处于高风险中患病/HIV的风险； （2）进行安全性，可接受性和使用率 在6周的30个未割礼的男性中，含有62％乙醇含有62％乙醇的局部杀菌剂； （3）在1030名男性中进行了2/3期随机双眼安慰剂对照试验，以进一步测试这种菌心的安全性，并确定其在降低使用微生物剂1-2年（平均21个月）的男性中所选性传播感染的疗效。对于AIM 1，我们计划了定量和定性数据收集方法的组合，包括焦点小组讨论，深入的开放式关键知情人访谈和结构化访谈，以指导开发社区支持，招聘和实现遵守干预方案。第1阶段试验将比较重复使用微生物使用的安全性和可接受性。第2/3期试验将进一步评估男性中这种微生物的安全性和功效，以减少已知或很可能对乙醇高度敏感的病原体感染的发生率，包括包蛋白病毒HSV-2和HIV，以及细菌病原体，这些病原体感染了阴茎的表皮，从而引起了遗传性的疾病。 62％的乙醇 - 发光剂 凝胶配方非常迅速，廉价且耐受耐受性，可商购，可在医疗保健环境中广泛使用，用于抗动感，并在美国提供家用的非处方。在肯尼亚男性的一系列逐步研究中，我们获得了有关该产品在阴茎上局部使用的安全性和可接受性的初步数据，目前正在评估男性定期使用该产品对女性伴侣阴道菌群的影响。