Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone

艾滋病毒患者对阿片类药物成瘾复发有助于寻求药物行为，不遵守 抗逆转录病毒治疗(ART)、治疗失败和病毒耐药性的发展。成功上瘾 治疗应该起到相反的作用。接受抗逆转录病毒治疗的阿片成瘾患者经常服用美沙酮 或丁丙诺啡，但这些药物受到监管限制，并不总是停止阿片类药物的使用， 在许多情况下是不可用的，并不是所有患者都能接受。 纳曲酮的维持是另一个可能有用的选择，因为它可以阻断阿片类药物的影响，并防止 如果按照指示行事，就会复发。它已经以每日服用的50毫克片剂的形式上市，最初得到了满足 临床医生的热情很高；然而，当大多数患者停止服用并复发时，热情就会减弱。 开发可能克服这些问题的长效配方的努力只实现了 最近，缓释制剂现已问世，并重新燃起了将其用于阿片类药物的兴趣 上瘾治疗。这些制剂还可以通过以下方式促进阿片成瘾患者对抗逆转录病毒治疗的坚持 防止复发。因此，这个项目的目标是测试一种植入性配方是否会如此缓慢 释放纳曲酮并阻断阿片类药物作用3个月(IN)比每天口服50毫克更有效 纳曲酮(ON)用于改善阿片成瘾患者对ART的依从性和治疗结果 开始他们的第一集艺术。 俄罗斯是一个理想的留学地点，因为它有批准的产品，大多数艾滋病毒患者是海洛因成瘾者， 俄罗斯法律不允许使用激动剂治疗，患者对纳曲酮的兴趣很高，而且合作 巴甫洛夫医科大学的研究团队在IN和ON方面拥有丰富的经验。来检验这一假设 在结果比On更好的HIV治疗结果中，我们建议48周，随机，双盲，双 200名新近脱毒的海洛因依赖者开始第一次抗逆转录病毒治疗的虚拟试验比较 圣彼得堡。主要结果将是24岁和24岁时病毒载量为400拷贝的患者的比例 48周。我们假设IN将比ON效果更好，因为它将与较少的复发和 更多的坚持。

Relapse to opioid addiction in patients with HIV contributes to drug-seeking behavior, non-adherence to antiretroviral therapy (ART), treatment failure, and the development of viral resistance. Successful addiction treatment should do the opposite. Opioid addicted patients receiving ART are often maintained on methadone or buprenorphine, but these medications are subject to regulatory limitations, do not always stop opioid use, are not available in many settings, and not acceptable to all patients. Naltrexone maintenance is another option that could be useful as it blocks opioid effects and prevents relapse if taken as directed. It has been available as a 50 mg tablet that is taken daily and was initially met with enthusiasm by clinicians; however enthusiasm waned when most patients stopped taking it and relapsed. Efforts to develop long-acting formulations that might overcome these problems were realized only very recently, and sustained release formulations are now available and have renewed interest in using it for opioid addiction treatment. These formulations may also facilitate adherence to ART in opioid addicted patients by preventing relapse. Accordingly, this project aims to test whether an implantable formulation that slowly releases naltrexone and blocks opioid effects for 3 months (IN) is more effective than 50 mg/day oral naltrexone (ON) for improving ART adherence and treatment outcome in opioid addicted patients who are beginning their first episode of ART. Russia is an ideal place to study IN since it has an approved product, most HIV patients are heroin addicts, Russian law does not permit agonist treatment, patient interest in naltrexone is high, and the collaborating research team at Pavlov Medical University has extensive experience with IN and ON. To test the hypothesis that IN results in better HIV treatment outcome than ON, we propose a 48-week, randomized, double blind, double- dummy trial comparing IN with ON in 200 recently detoxified heroin addicts beginning their first episode of ART in St. Petersburg. The primary outcomes will be the proportion of patients with a viral load of <400 copies at 24 and 48 weeks. We hypothesize that IN will work better than ON because it will be associated with less relapse and more adherence.