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

HIV患者阿片类药物成瘾的复发有助于寻求药物的行为， 抗逆转录病毒治疗（ART），治疗失败，以及病毒耐药性的发展。成功成瘾 治疗应该做相反的事情。接受抗逆转录病毒疗法的阿片类药物成瘾患者通常维持美沙酮治疗 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，并且不是所有患者都能接受的。 纳洛酮维持是另一种可能有用的选择，因为它可以阻断阿片类药物的作用， 如果按照指示服用，复发。它已作为一个50毫克的片剂，每天服用，最初是满足 临床医生的热情;然而，当大多数患者停止服用并复发时，热情减弱。 开发可能克服这些问题的长效制剂的努力只是在很短的时间内才实现。 最近，持续释放制剂现在是可用的，并且重新引起了将其用于阿片样物质的兴趣。 戒毒治疗这些制剂还可以通过以下方式促进阿片类药物成瘾患者对ART的依从性： 防止复发。因此，该项目旨在测试一种植入式制剂， 释放纳洛酮并阻断阿片类药物作用3个月（IN）比50 mg/天口服更有效 纳洛酮（ON）用于改善阿片类药物成瘾患者的ART依从性和治疗结果， 开始他们的第一集艺术。 俄罗斯是研究IN的理想场所，因为它有一个批准的产品，大多数艾滋病毒患者是海洛因成瘾者， 俄罗斯法律不允许激动剂治疗，患者对纳洛酮的兴趣很高， 巴甫洛夫医科大学的一个研究小组在IN和ON方面有着丰富的经验。为了验证这一假设， IN的结果比ON更好的HIV治疗结果，我们提出了一个48周，随机，双盲，双盲， 在200名最近戒毒的海洛因成瘾者中进行了比较IN和ON的模拟试验， 圣彼得堡。主要结果将是24岁时病毒载量<400拷贝的患者比例， 48周我们假设IN比ON效果更好，因为它与较少的复发相关， 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.