T. vaginalis Recurrence Among HIV+ Women

女性艾滋病毒患者中阴道毛滴虫的复发

• 批准号: 6866141
• 负责人: Patricia J Kissinger
• 金额: $ 22.42万
• 依托单位: LSU HEALTH SCIENCES CENTER
• 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 2009-07-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6866141
• 关键词: HIV infections; Trichomonas vaginalis; clinical trial phase IV; cooperative study; dosage; female; health behavior; human subject; human therapy evaluation; metronidazole; microorganism disease chemotherapy; microorganism interaction; patient oriented research; relapse /recurrence; secondary infection; sexually transmitted diseases

Trichomonas vaginalis (TV) has been associated with increased HIV vaginal shedding and HIV shedding is reduced among women who are treated for TV. Vaginal shedding of HIV can increase transmission. Proper treatment of TV, therefore, could have an impact on sexual and perinatal spread of HIV. TV recurrence rates among HIV+ women are high (i.e. 20-36%) and whether this recurrence is treatment failure or reinfection is not known. The present treatment recommendations have not been tested among HIV+ women. We propose two specific aims to examine treatment failure and reinfection. Aim # 1: To determine the if the 2 gram STAT dose of metronidazole is as effective as the 7 day 500 mg BID dose for TV treatment among HIV-infected women. This will be accomplished by conducting a randomized phase IV equivalency trial among HIV-infected women (N=508) attending two HIV outpatient clinics. Aim # 2: To describe the clinical and behavioral issues that are associate reinfection. A cohort study of TV positive women from Aim 1 who did not fail treatment (N approximately 406) will be followed at one and six months to examine risk factors for reinfection. All women at the two clinics will be screened using culture and those with TV, who are not pregnant, who are 16+ years of age and who do not have bacterial vaginosis (BV) will be eligible and will have their specimen tested for drug sensitivity. Women will be randomized to the STAT dose or the 7 day dose and they will be provided with STAT medication to deliver to their sex parters. Women will be asked to return 7 days after finishing the treatment and will be retested. Those who test TV positive will be considered treatment failures. Women who test TV negative will be followed at 1 and six months to investigate factors associated with 'einfection. The hypothesis is that the 2 gram STAT dose is equivalent to the 7 day dose and that most of recurrence is due to reinfection by an untreated sex partner. Information from this grant can be used to help tailor guidelines for the treatment of TV among HIV-infected women

阴道（TV）的Trichomonas Vaginalis（电视）与艾滋病毒阴道脱落的增加有关，在接受电视治疗的女性中，艾滋病毒脱落减少。艾滋病毒的阴道脱落会增加传播。因此，对电视的适当治疗可能会影响艾滋病毒的性和围产期传播。艾滋病毒+女性中的电视复发率很高（即20-36％），而这种复发是治疗失败还是尚不清楚。目前的治疗建议尚未在HIV+女性中进行测试。我们提出了两个特定的目的，以检查治疗失败和再感染。 AIM＃1：确定甲硝唑的2克统计剂量是否与7天500毫克竞标剂量一样有效。这将通过进行随机IV等效试验来实现 在受HIV感染的妇女（n = 508）中，参加了两个HIV门诊诊所。目的＃2：描述临床和行为问题的临床和行为问题。对AIM 1的电视阳性女性的队列研究将在一个和六个月的时间内未通过治疗失败（n个大约406），以检查危险因素重新感染。 这两个诊所的所有妇女都将使用文化进行筛查，而那些未怀孕，16岁以上并且没有细菌性阴道病（BV）的电视妇女将符合条件，并将对其标本进行药物敏感性测试。妇女将被随机分配给统计剂量或7天剂量，并将为她们提供统计药物以交付给他们的性行为。将要求妇女在完成治疗后7天返回，并将重新测试。那些测试电视阳性的人将被视为治疗失败。 测试电视阴性的妇女将在1和六个月的时间内进行调查与“感染”相关的因素。假设是2克统计剂量等效于7天剂量，并且大部分复发是由于未经处理的性伴侣的重新感染所致。该赠款的信息可用于帮助量身定制艾滋病毒感染妇女的电视治疗指南