Topic III: Hormonal influences on HIV disease and co-morbidities - Effect of contraceptive methods on natural history of HIV: Studies from the Mombasa Cohort
Topic III: Hormonal influences on HIV disease and co-morbidities - Effect of contraceptive methods on natural history of HIV: Studies from the Mombasa Cohort
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DOI：
10.1097/01.qai.0000167030.18278.0e
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发表时间：
2005-03-01
影响因子：
3.6
通讯作者：
Duerr, A
中科院分区：
文献类型：
--
作者：
Baeten, JM;Lavreys, L;Duerr, A
目的评估类固醇激素避孕方法对肯尼亚、泰国和津巴布韦妇女早期HIV感染的临床病程的影响。MethodsWomen有记录的HIV感染和CD 4细胞计数超过500个细胞/μl，无症状或早期（轻度疾病）的妇女被邀请参加观察性队列研究，6个月随访4年。通过访谈、体格检查和采集用于CD 4细胞计数、HIV定量和分型的血液样本收集基线信息。每次随访时重复相同的程序。研究终点包括HIV疾病进展、机会性感染（OI）的发生率和疾病进展的替代标志物，包括CD 4细胞计数和病毒载量的变化。将根据使用的避孕方法对这些数据进行分析。该研究的目的是招募共220个用户的DMPA，Norplant，COC和类似数量的妇女不使用激素避孕的研究sites.ResultsRecruitment的研究开始于2000年，到2002年中期，共招募了395名妇女，其中大多数是从内罗毕（52%）和哈拉雷（23%）。四分之一的妇女在登记时使用COC，42%使用DMPA，5%使用Norplant，其余28%使用非激素避孕药。几乎所有Norplant用户都来自曼谷，几乎所有COC和DMPA用户都来自两个非洲研究中心。迄今为止，队列中几乎没有出现艾滋病毒终点。尽管选择了细胞计数超过500个/μl的妇女，但哈拉雷登记时的CD 4细胞计数低于内罗毕。对CD 4细胞下降率的初步评估显示，哈拉雷的下降率（平均每年损失102个细胞/μl; SD 244）高于内罗毕（平均每年损失55个细胞/μl; SD 283）。2003年继续招募妇女加入这一队列，并将继续对登记的妇女进行随访，直至预定的四个完整年份。这项研究估计有80%的权力，以证明口服避孕药和非激素用户之间的CD 4细胞下降率的两倍的差异，以及DMPA和非激素users.ConclusionRecruitment之间的研究一直很困难，特别是因为这项研究是不能提供任何承诺的治疗HIV阳性的妇女。目前正在制定计划，向CD 4细胞计数降至200个细胞/μl以下的妇女提供抗逆转录病毒治疗，并将在记录良好的类固醇激素避孕药使用者队列中评估抗逆转录病毒治疗的临床反应。巴西不得不放弃招募志愿者参加这项研究，因为国家治疗标准意味着在志愿者有资格接受治疗之前，最多只能进行短期观察，而且事实证明，很难确定CD 4细胞计数超过研究门槛的艾滋病毒阳性妇女。
ObjectiveTo assess the effect of steroid hormone contraceptive methods on the clinical course of early HIV infection among women in Kenya, Thailand and Zimbabwe.MethodsWomen with documented HIV infection and CD4 cell counts over 500 cells/μl who were asymptomatic or had early (mild disease) were invited to participate in an observational cohort study with 6-monthly follow-up visits for 4 years. Baseline information was collected through interview, physical examination and blood sample collection for CD4 cell count, HIV quantification and subtyping. Identical procedures were repeated at each follow-up visit. Study endpoints include HIV disease progression, the incidence of opportunistic infections (OI), and surrogate markers of disease progression, including changes in CD4 cell counts and viral load. These will be analysed according to the contraceptive methods used. The study aimed to recruit a total of 220 users each of DMPA, Norplant, COC and a similar number of women not using hormonal contraception over the study sites.ResultsRecruitment to the study started in 2000 and by the middle of 2002 a total of 395 women had been recruited, the majority of whom were from Nairobi (52%) and Harare (23%). One quarter of women were using COC, 42% DMPA, 5% Norplant and the remaining 28% non-hormonal contraception at enrolment. Almost all the Norplant users were from Bangkok and almost all the COC and DMPA users were from the two African sites. Few HIV endpoints have occurred in the cohort to date. CD4 cell counts at enrolment were lower in Harare than in Nairobi, despite the selection of women with counts above 500 cells/μl. Preliminary assessment of the rates of CD4 cell decline showed a higher rate in Harare (mean annual loss of 102 cells/μl; SD 244) than in Nairobi (mean annual loss of 55 cells/μl; SD 283). Recruitment into the cohort continued through 2003 and follow-up will continue for the enrolled women up to the scheduled four completed years. The study is estimated to have 80% power to demonstrate twofold differences in the rates of CD4 cell decline between oral contraceptive and non-hormonal users, as well as between DMPA and non-hormonal users.ConclusionRecruitment into the study has been difficult, particularly as the study was not able to offer any promise of therapy for HIV-positive women. Plans to provide antiretroviral therapy to those women whose CD4 cell counts decline below 200 cells/μl are under development and will allow the clinical response to antiretroviral therapy to be assessed in the well-documented cohort of steroid hormone contraception users. Recruitment to the study had to be abandoned in Brazil as the national standards for therapy meant that there would at best be only a short period of observation before the volunteers qualified for treatment, and it proved very difficult to identify HIV-positive women with CD4 cell counts over the study threshold for enrolment.