Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

减少酗酒以优化艾滋病毒/艾滋病的治疗和预防

基本信息

批准号：
8516410
负责人：
Lynn Elizabeth Fiellin
金额：
$ 67.86万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8516410
关键词：
AIDS prevention AIDS/HIV problem Address Adherence Adverse effects Affect Alcohol abuse Alcohol consumption Alcohol dependence Alcohols Area Behavior Therapy Behavioral Biological Assay CD4 Lymphocyte Count Caring Clinic Collection Controlled Clinical Trials Counseling Data Data Analyses Dependence Detection Development Disease Disease Progression Double-Blind Method Drug Formulations Frequencies Funding Goals HIV HIV drug resistance Heavy Drinking Hepatic Hepatotoxicity Highly Active Antiretroviral Therapy Immune system Immunologic Markers Individual Intention Intervention Studies Lead Liver Function Tests Measures Medical Medication Management Minor Mutation Naltrexone National Institute on Alcohol Abuse and Alcoholism Oral Outcome Outcome Study Patients Pharmaceutical Preparations Pharmacotherapy Pharmacy facility Placebo Control Placebos Prevention Provider RNA Randomized Reporting Research Research Personnel Risk Risk-Taking Role Sampling Series Site Substance Use Disorder Techniques Training Variant Viral Viral Markers Woman addiction brief intervention comparative efficacy deep sequencing drinking effective therapy evidence base experience follow-up immune function improved liver injury medication compliance meetings men novel patient population placebo controlled study primary care setting response sex risk therapy adherence therapy design transmission process treatment effect

项目摘要

PROJECT SUMMARY/ABSTRACT Few treatments have been evaluated to reduce the impact of heavy drinking, alcohol abuse and dependence on HIV-infected patients. These levels of alcohol consumption are associated with decreased adherence to highly active antiretroviral therapy (HAART), an increased likelihood of viral mutations, enhanced disease progression, promotion of liver injury, and increased sexual risk taking. Naltrexone, when combined with counseling, is an effective treatment for heavy drinking, alcohol abuse and dependence yet there are no data on its use or efficacy in HIV-infected patients. The proposed study compares naltrexone to placebo in a 24- week randomized double-blind placebo-controlled clinical trial in HAART-non-adherent HIV-infected patients with heavy drinking, alcohol abuse or dependence (N=154 ) in an HIV clinic. To determine the long-term impact of treatment, all patients will undergo follow-up at 9 and 12 months. Patients randomized to naltrexone will initially receive the oral daily formulation and, if tolerated, will be transferred to the monthly extended release formulation. All patients will receive the counseling platform of Medication Management (MM) combined with Medication Coaching (MC) (MM/MC). MM/MC is a compound manualized treatment intended to approximate the type of treatment that would be suitable for implementation in an HIV primary care setting. It focuses on reducing heavy drinking (MM) and improving medication adherence (MC) through a series of brief interventions delivered by a medically trained provider. Data analyses will be conducted on the intention to treat sample of patients randomly assigned to receive naltrexone + MM/MC versus placebo + MM/MC. The primary study outcome is adherence to HAART medications. Secondary study outcomes include frequency of heavy drinking, HIV viral mutations (using standard assays and ultra-deep sequencing), change in CD4 lymphocyte counts and HIV RNA, alcohol-HAART hepatotoxicity, and sexual risk behaviors. The novel aspects of this proposal include: 1) Integrated on-site alcohol and HIV treatment; 2) The use of extended release naltrexone which is likely to improve adherence in this patient population for whom medication adherence is challenging; 3) The use of several measures for HAART adherence including pharmacy refill data; 4) The use of sophisticated techniques for examining the development of new viral mutations including the detection of new minor variants; and 5) Collection of detailed data on the hepatic effects of treatment. The proposed study, conducted by an experienced team of HIV and addiction researchers, will help define the role of naltrexone and evidence-based counseling in HAART-non-adherent subjects with alcohol problems.

项目概要/摘要很少有治疗方法能够减少酗酒、酒精滥用和酒精依赖的影响关于艾滋病毒感染者。这些饮酒水平与饮酒依从性降低有关高效抗逆转录病毒疗法（HAART），病毒突变的可能性增加，疾病加剧进展、促进肝损伤以及增加性行为风险。纳曲酮与咨询是治疗酗酒、酒精滥用和酒精依赖的有效方法，但尚无数据关于其在艾滋病毒感染者中的使用或功效。拟议的研究在 24 小时内比较了纳曲酮和安慰剂在未接受 HAART 的 HIV 感染患者中进行的为期一周的随机双盲安慰剂对照临床试验在 HIV 诊所酗酒、酗酒或依赖酒精 (N=154)。以确定长期为了考虑治疗的影响，所有患者都将在第 9 个月和第 12 个月接受随访。患者随机接受纳曲酮治疗最初将接受每日口服制剂，如果耐受，将转为每月延长剂量释放制剂。所有患者都将接受药物管理（MM）咨询平台与药物指导（MC）（MM/MC）相结合。 MM/MC 是一种复合手法治疗，旨在大致适合在艾滋病毒初级保健机构中实施的治疗类型。它通过一系列简短的说明，重点关注减少酗酒 (MM) 和提高药物依从性 (MC) 由经过医学培训的提供者提供的干预措施。将根据以下意图进行数据分析治疗随机分配接受纳曲酮 + MM/MC 与安慰剂 + MM/MC 的患者样本。这主要研究结果是坚持使用 HAART 药物。次要研究结果包括频率酗酒、HIV 病毒突变（使用标准检测和超深度测序）、CD4 变化淋巴细胞计数和 HIV RNA、酒精-HAART 肝毒性和性危险行为。小说该提案的各个方面包括： 1) 综合现场酒精和艾滋病毒治疗； 2）使用扩展释放纳曲酮，这可能会提高药物治疗患者群体的依从性坚持是具有挑战性的； 3) 使用多种措施来保证 HAART 依从性，包括药房补充数据; 4) 使用复杂的技术来检查新病毒突变的发展，包括检测新的微小变异； 5) 收集治疗对肝脏影响的详细数据。这拟议的研究由经验丰富的艾滋病毒和成瘾研究人员团队进行，将有助于确定这一角色纳曲酮的使用和对有酒精问题的非 HAART 受试者的循证咨询。