参与单纯疱疹病毒2型抑制以减少HIV-1传播试验的HIV-1不一致伴侣的特征：伴侣研究
Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.
作者信息
Lingappa Jairam R, Kahle Erin, Mugo Nelly, Mujugira Andrew, Magaret Amalia, Baeten Jared, Bukusi Elizabeth A, Cohen Craig R, Katabira Elly, Ronald Allan, Kiarie James, Farquhar Carey, Stewart Grace John, Makhema Joseph, Essex M, Were Edwin, Fife Kenneth, Debruyn Guy, Gray Glenda, McIntyre James, Manongi Rachel, Kapiga Saidi, Coetzee David, Allen Susan, Inambao Mubiana, Kayitenkore Kayitesi, Karita Etienne, Kanweka William, Delany Sinead, Rees Helen, Vwalika Bellington, Coombs Robert W, Morrow Rhoda, Whittington William, Corey Lawrence, Wald Anna, Celum Connie
机构信息
Department of Global Health, University of Washington, Seattle, Washington, United States of America.
出版信息
PLoS One. 2009;4(4):e5272. doi: 10.1371/journal.pone.0005272. Epub 2009 Apr 30.
BACKGROUND
The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.
METHODS
HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.
RESULTS
Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and >500 relative to <350, respectively, p<0.001).
CONCLUSIONS
The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00194519.
背景
伴侣单纯疱疹病毒2型/人免疫缺陷病毒1型传播研究（伴侣研究）是一项三期、安慰剂对照试验，旨在研究每日使用阿昔洛韦抑制生殖器疱疹（单纯疱疹病毒2型）对同时感染人免疫缺陷病毒1型/单纯疱疹病毒2型的人群的影响，以减少将人免疫缺陷病毒1型传播给其对人免疫缺陷病毒1型易感的伴侣，该研究需要招募人免疫缺陷病毒1型血清学不一致的异性恋伴侣。我们描述了该队列的基线特征。
方法
人免疫缺陷病毒1型血清学不一致的异性恋伴侣，其中感染人免疫缺陷病毒1型的伴侣单纯疱疹病毒2型血清学呈阳性，CD4细胞计数≥250个/微升且未接受抗逆转录病毒治疗，在东非和南非的14个地点入组。评估了人口统计学、行为学、临床和实验室特征。
结果
在入组的3408对人免疫缺陷病毒1型血清学不一致的伴侣中，67%感染人免疫缺陷病毒1型的伴侣为女性。伴侣同居的中位数为5年（范围2 - 9年），28%的伴侣报告在入组前一个月有未采取保护措施的性行为。在对人免疫缺陷病毒1型易感的参与者中，86%的女性和59%的男性单纯疱疹病毒2型血清学呈阳性。其他实验室诊断的性传播感染不常见（<5%），但14%感染人免疫缺陷病毒1型的女性感染了阴道毛滴虫。感染人免疫缺陷病毒1型参与者的基线CD4细胞计数中位数为462个/微升，人免疫缺陷病毒1型血浆RNA中位数为4.2 log(10)拷贝/毫升。在调整年龄和非洲地区后，人免疫缺陷病毒1型RNA水平的相关因素包括男性性别（+0.24 log(10)拷贝/毫升；p<0.001）和CD4细胞计数（CD4为350 - 499和>500时相对于<350分别为-0.25和-0.55 log(10)拷贝/毫升，p<0.001）。
结论
伴侣研究成功在非洲招募了3408对有高风险传播人免疫缺陷病毒1型的异性恋、人免疫缺陷病毒1型血清学不一致的伴侣。对该队列的随访将评估阿昔洛韦抑制单纯疱疹病毒2型在预防人免疫缺陷病毒1型传播方面的疗效，并深入了解决定异性传播人免疫缺陷病毒1型的生物学和行为因素。
试验注册
ClinicalTrials.gov NCT00194519。
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