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

海洛因成瘾者对艾滋病毒治疗的依从性：口服纳曲酮与缓释纳曲酮

• 批准号: 8288300
• 负责人: GEORGE Edward WOODY
• 金额: $ 38.28万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-18 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8288300
• 关键词: Adherence; Agonist; Alcohol or Other Drugs use; Appointments and Schedules; Behavior; Buprenorphine; CD4 Lymphocyte Count; Counseling; Development; Disease; Double-Blind Method; Drug Formulations; Drug Metabolic Detoxication; Drug usage; HIV; HIV therapy; Heroin; Heroin Dependence; Implant; Laws; Lead; Maintenance; Maintenance Therapy; Measures; Mediating; Medical; Methadone; Methods; Naltrexone; Obsessive compulsive behavior; Opiate Addiction; Opioid; Oral; Patients; Pharmaceutical Preparations; Placebos; Plasma; Randomized; Relapse; Research; Resistance; Risk Behaviors; Russia; Science; Symptoms; Tablets; Testing; Time; Treatment Failure; Treatment outcome; Universities; Urine; Viral Load result; Work; addiction; antiretroviral therapy; comparative efficacy; drug seeking behavior; experience; high risk behavior; improved; interest; meetings; prevent; primary outcome; programs; response; secondary outcome; therapy adherence; treatment response; trial comparing; viral resistance

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.

HIV 患者阿片类药物成瘾复发会导致寻求药物的行为、不遵守药物治疗 抗逆转录病毒治疗 (ART)、治疗失败和病毒耐药性的产生。成功上瘾 治疗应该起到相反的作用。接受 ART 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，并不总是停止使用阿片类药物， 在许多情况下并不可用，并且并非所有患者都能接受。 纳曲酮维持治疗是另一种有用的选择，因为它可以阻止阿片类药物的作用并防止 如果按指示服用，则会复发。它已以 50 毫克片剂形式提供，每天服用，并最初得到满足 临床医生的热情；然而，当大多数患者停止服用该药并病情复发时，热情就减弱了。 开发可以克服这些问题的长效制剂的努力仅取得了非常大的成功。 最近，缓释制剂现已上市，人们对将其用于阿片类药物重新产生了兴趣 成瘾治疗。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可植入制剂是否能缓慢地 释放纳曲酮并阻断阿片类药物作用 3 个月 (IN) 比 50 毫克/天口服更有效 纳曲酮 (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 ART。 俄罗斯是学习IN的理想地点，因为它有经过批准的产品，大多数艾滋病毒患者都是海洛因成瘾者， 俄罗斯法律不允许激动剂治疗，患者对纳曲酮的兴趣很高，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。为了检验以下假设 IN 的 HIV 治疗结果优于 ON，我们建议进行 48 周、随机、双盲、双 虚拟试验对 200 名最近戒毒的海洛因成瘾者进行了 IN 和 ON 的比较，他们开始了第一次 ART 圣彼得堡。主要结果是24岁时病毒载量<400拷贝的患者比例 48 周。我们假设 IN 会比 ON 效果更好，因为它会减少复发，并且 更多的坚持。

项目成果

Depression, substance use, viral load, and CD4+ count among patients who continued or left antiretroviral therapy for HIV in St. Petersburg, Russian Federation.

俄罗斯联邦圣彼得堡继续或停止接受 HIV 抗逆转录病毒治疗的患者的抑郁、物质使用、病毒载量和 CD4 计数。

• DOI: 10.1080/09540121.2014.959464
• 发表时间: 2015
• 期刊: AIDS care
• 影响因子: 1.7
• 作者: Pecoraro,Anna;Mimiaga,Matthew;O'Cleirigh,Conall;Safren,StevenA;Blokhina,Elena;Verbitskaya,Elena;Yaroslavtseva,Tatiana;Ustinov,Andrey;Lioznov,DmitryA;Zvartau,Edwin;Krupitsky,Evgeny;Woody,GeorgeE
• 通讯作者: Woody,GeorgeE

Proactive coping and spirituality among patients who left or remained in antiretroviral treatment in St Petersburg, Russian Federation.

俄罗斯联邦圣彼得堡离开或继续接受抗逆转录病毒治疗的患者的积极应对和灵性。

• DOI: 10.1080/09540121.2015.1096895
• 发表时间: 2016
• 期刊: AIDS care
• 影响因子: 1.7
• 作者: Pecoraro,Anna;Pacciolla,Aureliano;O'Cleirigh,Conall;Mimiaga,Matthew;Kwiatek,Piotr;Blokhina,Elena;Verbitskaya,Elena;Krupitsky,Evgeny;Woody,GeorgeE
• 通讯作者: Woody,GeorgeE