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The Implementation and Appraisal of a Novel Confirmatory HIV-1 Testing Algorithm in the Microbicides Development Programme 301 Trial (MDP301)

机译：实施和新型确证HIV-1测试算法中的杀微生物剂发展计划301试验与评价（mDp301）

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We describe the application of a novel HIV confirmatory testing algorithm to determine the primary efficacy endpoint in a large Phase III microbicide trial. 9385 women were enrolled between 2005 and 2009. Of these women, 537 (6%) had at least one positive HIV rapid test after enrolment. This triggered the use of the algorithm which made use of archived serum and Buffy Coat samples. The overall sample set was >95% complete. 419 (78%) of the rapid test positive samples were confirmed as primary endpoints using a combination of assays for the detection of HIV-specific antibodies (EIA's and Western Blot), and for components of the virus itself (PCR for the detection of nucleic acids and EIA for p24 antigen). 63 (12%) cases were confirmed as being HIV-positive at screening or enrolment and 55 (10%) were confirmed as HIV negative. The testing algorithm confirmed the endpoint at the same visit as that of the first positive rapid test in 90% of cases and at the time of the preceding visit in 10% of cases. Of the 63 cases which were subsequently confirmed to be HIV-1 positive at or before enrolment, 54 specimens contained no detectable HIV antibodies at screening or enrolment. However, 43 were positive using an EIA which detects both HIV antigen and antibody and also had a positive p24 antigen or HIV PCR test, which was highly suggestive of acute infection. There were 6 unusual cases which had undetectable HIV-1 DNA or RNA. In 4 of the 6 cases the presence of HIV-1-specific antibodies was confirmed by Western Blot. One of these cases with an indeterminate Western Blot was a previous vaccine trial participant. The algorithm served the objectives of the study well and can be recommended for use in determining HIV as an endpoint in clinical trials.Trial RegistrationISRCTN.org
机译：我们描述了一种新型的HIV确证性测试算法在大型III期杀微生物剂试验中确定主要疗效终点的应用。在2005年至2009年之间，共有9385名妇女入选。其中，有537名（6％）入选后至少进行了一项艾滋病毒快速检测阳性。这触发了算法的使用，该算法利用了存档的血清和Buffy Coat样品。整个样本集完成率> 95％。使用检测HIV特异性抗体（EIA和Western Blot）以及检测病毒本身成分（PCR检测核酸）的组合检测，将419个（78％）快速检测阳性样品确认为主要终点酸和EIA（针对p24抗原）。在筛查或入组时确认为HIV阳性的病例为63（12％），而对HIV阴性的确诊为55（10％）。测试算法在90％的病例中与第一次阳性快速检测相同的访视时确认了终点，在前一次访视时有10％的病例确认了终点。在随后在入组时或入组前被确认为HIV-1阳性的63例病例中，有54个样本在筛查或入组时未检测到HIV抗体。然而，使用EIA可以检测出43个阳性结果，该EIA既可以检测HIV抗原又可以检测抗体，并且p24抗原或HIV PCR检测结果均为阳性，这强烈提示急性感染。有6例异常病例的HIV-1 DNA或RNA无法检测到。 Western Blot证实6例中有4例存在HIV-1特异性抗体。其中一个带有不确定的Western Blot的病例是先前的疫苗试验参与者。该算法很好地达到了研究目的，可以推荐用于确定HIV作为临床试验的终点。

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