PREVENTION OF HIV SHEDDING IN WOMEN--TRIAL OF VITAMIN A

预防女性艾滋病毒传播——维生素 A 的试验

• 批准号: 6148303
• 负责人: JOAN K KREISS
• 金额: $ 53.54万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6148303
• 关键词: AIDS education /prevention; Africa; HIV infections; clinical research; clinical trials; communicable disease transmission; dietary supplements; female; human immunodeficiency virus 1; human subject; human therapy evaluation; nutrition related tag; retinoids; vitamin therapy

DESCRIPTION: Despite encouraging advances in treating and preventing HIV infection in North America and Western Europe, the epidemic continues to spread rapidly in many parts of the world. The need for new strategies to prevent heterosexual and vertical transmission remains pressing. HIV-1 can be detected in genital tract secretions of infected individuals, and there is epidemiologic evidence that this is a marker of enhanced infectivity. Recent studies of correlates of genital tract shedding of HIV-1 DNA in infected women have found that lower serum concentrations of vitamin A were strongly associated with detection of HIV-1 DNA in vaginal secretions. Vitamin a deficiency leads to characteristic pathological changes in mucosal epithelium, including the vagina, and is correlated with immune dysfunction in both HIV-1 infected and uninfected individuals. In addition, maternal vitamin A deficiency has been associated with significantly increased risk of vertical HIV-1 transmission. We propose a randomized double-blind placebo-controlled trial to assess the effect of vitamin A supplementation on the prevalence and quantity of HIV-1 DNA and RNA in cervical and vaginal secretions in 400 HIV-infected nonpregnant women in Mombasa, Kenya. Participants will be randomized to receive six weeks of daily dosage of either 10,000 IU vitamin A or placebo. Cervical and vaginal swabs will be obtained at enrollment and at six weeks for detection and quantification of HIV-1 DNA and RNA. In addition, venous blood will be obtained at the two time points for quantification of plasma HIV-1 RNA, CD4 lymphocyte count, and serum vitamin A levels. Normalization of vitamin A status in supplemented HIV-1 infected women may improve genital mucosal integrity and immunity, thereby potentially decreasing the infectiousness of these women. In a pilot study, we found that vitamin A supplementation resulted in a two-fold decrease in vaginal HIV-1 DNA detection. If this preliminary result is confirmed in a full-scale clinical trial, vitamin A supplementation may offer a simple inexpensive intervention to decrease heterosexual and vertical transmission of HIV-1 in the developing world.

描述：尽管在治疗和预防艾滋病毒方面取得了令人鼓舞的进展 在北美和西欧感染，疫情继续蔓延 在世界许多地方迅速蔓延。需要新的战略来预防 异性恋和垂直传播仍然很紧迫。可以检测到HIV-1 在感染者的生殖道分泌物中，有流行病学 有证据表明这是传染性增强的标志。最新的研究 发现感染女性生殖道脱落HIV-1 DNA的相关因素 较低的血清维生素A浓度与 阴道分泌物中HIV-1DNA的检测维生素a缺乏导致 粘膜上皮的特征性病理改变，包括 阴道，并与HIV-1感染和免疫功能障碍有关 未受感染的个体。此外，孕妇的维生素A缺乏症 与艾滋病毒-1垂直传播风险显著增加有关。 我们提出了一项随机、双盲、安慰剂对照试验来评估 补充维生素A对HIV-1DNA流行率和DNA含量的影响 400例未孕HIV感染者宫颈和阴道分泌物中的DNA和RNA 肯尼亚蒙巴萨的妇女。参与者将被随机分配到六周内 每日剂量为10,000国际单位的维生素A或安慰剂。宫颈和阴道 在注册时和六个星期内将获得拭子以进行检测和 HIV-1DNA和RNA的定量检测。此外，还将采集静脉血 在两个时间点对血浆HIV-1RNA、CD4淋巴细胞进行定量 计数和血清维生素A水平。人体内维生素A水平的正常化 补充HIV-1感染妇女可改善生殖器粘膜完整性和 免疫力，从而潜在地降低这些妇女的传染性。在……里面 在一项初步研究中，我们发现补充维生素A导致了两倍的 阴道内HIV-1DNA检测下降。如果这个初步结果是 在全面的临床试验中得到证实，维生素A补充剂可能会提供 减少异性恋和垂直性行为的简单、廉价的干预措施 艾滋病毒-1在发展中国家的传播。