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: 8298404
• 负责人: GEORGE Edward WOODY
• 金额: $ 1.82万
• 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 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8298404
• 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; Health; 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; 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; Health; 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

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: This study will assess the impact of oral naltrexone 50 mg/day vs. a sustained-release naltrexone implant on response to antiretroviral therapy (ART) in opioid addicted patients beginning ART in St. Petersburg, Russia. It will randomize 260 recently detoxified opioid addicts beginning ART to a 48-week course of biweekly drug counseling with oral naltrexone 50 mg/day + placebo naltrexone implant, or placebo tablet + naltrexone implant. The primary outcome will be response to ART as measured by reduction in viral load.

描述（由申请人提供）：艾滋病毒患者中阿片类药物成瘾的复发有助于寻求药物的行为，对抗逆转录病毒疗法（ART），治疗失败以及病毒抗性的发展。成功的成瘾治疗应相反。阿片类药物上瘾的接受ART的患者通常以美沙酮或丁丙诺啡的方式维持，但是这些药物受到调节限制的约束，并不总是停止使用阿片类药物，在许多情况下不可用，并且不可接受所有患者。 Naltrexone维护是另一种可能有用的选择，因为它会阻止阿片类药物效应并防止按照指示采取复发。它已作为50毫克的平板电脑可用，每天都会服用，最初受到临床医生的热情。但是，当大多数患者停止服用并复发时，热情就会减弱。开发可能要克服这些问题的长效表述的努力仅仅是最近才实现的，现在可以使用持续的释放制剂，并重新兴趣将其用于阿片类药物成瘾治疗。这些配方还可以通过预防复发来促进阿片类药物上瘾患者的ART依从性。因此，该项目旨在测试一种可缓慢释放纳曲酮并阻止阿片类药物作用3个月（in）的植入式配方是否比50 mg/天口服纳曲酮（ON）更有效，以改善阿片类药物上瘾的患者的艺术依从性和治疗结果，这些患者正在开始艺术第一集。俄罗斯是一个理想的学习场所，因为它拥有批准的产品，大多数艾滋病毒患者是海洛因成瘾者，俄罗斯法律不允许激动剂治疗，患者对纳曲酮的兴趣很高，并且Pavlov医科大学的合作研究团队具有丰富的经验。为了检验以下假设：在结果比ON的结果更好的艾滋病毒治疗结果中，我们提出了一项为期48周，随机，双盲，双假试验的假设，与ON与200个最近排毒的海洛因成瘾者进行了比较，开始了在圣彼得堡的第一集。主要结果是在24和48周时病毒载荷<400份的患者比例。我们假设其中的工作能力要好于效果更好，因为它将与复发较少和更坚持相关。公共卫生相关性：本研究将评估口服纳曲酮50 mg/天的口服纳曲酮与持续释放的纳曲酮对抗逆转录病毒疗法（ART）的反应对阿片类药物成瘾的患者的反应，从而在俄罗斯圣彼得堡开始艺术。它将随机分配260个最近排毒的阿片类药物成瘾者，开始为48周的每两周一次的药物咨询，口服纳曲酮50 mg/day +安慰剂纳曲酮植入物或安慰剂片 +纳曲酮植入物。主要结果将是对ART的反应，如病毒负荷减少所测量。