Pharmacotherapy for alcohol consumptionin HIV-infected women: randomized trial

HIV 感染女性饮酒的药物治疗：随机试验

• 批准号: 8718950
• 负责人: Robert L Cook
• 金额: $ 49.62万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-25 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8718950
• 关键词: AIDS/HIV problem; Address; Adherence; Alcohol abuse; Alcohol consumption; Alcohol dependence; Alcohols; Ambulatory Care Facilities; Anti-Retroviral Agents; Behavioral Sciences; Biological Markers; CD4 Lymphocyte Count; Chicago; Chronic Disease; Clinic; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Cohort Studies; Disease Progression; District of Columbia; Effectiveness; Enrollment; Epidemiology; Exclusion Criteria; Functional disorder; Guidelines; HIV; HIV Infections; Health; Immunologics; Individual; Interdisciplinary Study; Intervention; Intervention Trial; Measures; Naltrexone; National Institute on Alcohol Abuse and Alcoholism; Outcome; Outcomes Research; Outpatients; Participant; Persons; Pharmaceutical Preparations; Pharmacotherapy; Pilot Projects; Placebos; Population; Principal Investigator; Procedures; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Research; Research Infrastructure; Risk Factors; Sampling; Series; Serum; Site; Treatment Effectiveness; Treatment outcome; Viral Load result; Woman; Work; alcohol abuse therapy; antiretroviral therapy; base; clinical care; cohort; cooking; design; drinking; hazardous drinking; high risk; high risk sexual behavior; improved; innovation; medication compliance; men; public health relevance; randomized trial; substance abuse treatment; topiramate

DESCRIPTION (provided by applicant): Hazardous alcohol consumption is common in HIV-infected women and is associated with significant harm. The primary objective of this application is to evaluate whether a prescription medication will reduce hazardous alcohol consumption and its consequences in HIV-infected women. The central hypothesis is that women who receive active medication (vs. placebo medication) will decrease their alcohol consumption and have improved health outcomes. The specific aims are to determine whether a drinking-reduction medication (naltrexone or topiramate), provided to HIV-infected women with hazardous drinking (>7 drinks/wk or >4 drinks/occasion) will result in reduced alcohol consumption and improved HIV-related outcomes (antiretroviral medication adherence, reduced HIV disease progression, and reduced risky sexual behavior).This study represents the clinical trial component of our Consortiums for HIV/AIDS and Alcohol-Related Outcomes Research Trials (CHAART), a series of three inter-related projects surrounding a central Core. We propose a randomized controlled trial involving 240 HIV-infected women with hazardous drinking recruited from outpatient clinics and research settings in Chicago IL, Washington DC, Jacksonville FL, and Brooklyn NY. Women will be randomized to receive medication or placebo for 4 months; main outcomes will be assessed at 2-months, 4-months, and 7-months. Many women in the trial will also be participants in the Women's Interagency HIV Study, a large ongoing cohort of HIV-infected women. The study will build upon a currently-established pilot study in which we have established the study procedures, identified key measures, and developed the research infrastructure needed to fully implement this multi-site, randomized clinical trial. The proposed work is innovative because pharmacologic treatment for alcohol has not been evaluated in HIV-infected women outside of substance abuse treatment settings, and alcohol medication will be chosen based on an individual assessment. The expected outcome supporting the effectiveness of this treatment would transform the approach to clinical management of hazardous drinking in clinics serving HIV-infected women, and could readily be adapted to women with other chronic disease.

描述（由申请人提供）：有害饮酒在感染艾滋病毒的女性中很常见，并且会造成重大伤害。该应用程序的主要目的是评估处方药是否会减少危险的饮酒量及其对艾滋病毒感染女性的影响。中心假设是，接受活性药物（与安慰剂药物相比）的女性会减少饮酒量并改善健康状况。具体目的是确定向危险饮酒（每周> 7 次饮酒或> 4 次/次）的艾滋病毒感染女性提供的减少饮酒药物（纳曲酮或托吡酯）是否会导致饮酒量减少并改善艾滋病毒感染情况。相关结果（抗逆转录病毒药物依从性、减少艾滋病毒疾病进展和减少危险性行为）。这项研究代表了我们艾滋病毒/艾滋病和酒精相关结果研究试验联盟的临床试验组成部分（CHAART），围绕一个中央核心的一系列三个相互关联的项目。我们提议开展一项随机对照试验，招募了 240 名患有危险饮酒的 HIV 感染女性，这些女性是从伊利诺斯州芝加哥、华盛顿特区、佛罗里达州杰克逊维尔和纽约州布鲁克林的门诊诊所和研究机构招募的。女性将被随机分配接受药物或安慰剂治疗 4 个月；主要成果将在2个月、4个月和7个月时进行评估。参与试验的许多女性还将参加妇女机构间艾滋病毒研究，这是一个正在进行的大型艾滋病毒感染妇女群体研究。该研究将建立在目前已建立的试点研究的基础上，在该研究中，我们制定了研究程序，确定了关键措施，并开发了全面实施这项多中心、随机临床试验所需的研究基础设施。这项拟议的工作具有创新性，因为在药物滥用治疗环境之外，尚未对感染艾滋病毒的女性进行酒精药物治疗评估，并且将根据个人评估选择酒精药物治疗。支持这种治疗有效性的预期结果将改变为感染艾滋病毒的妇女提供服务的诊所中危险饮酒的临床管理方法，并且可以很容易地适应患有其他慢性疾病的妇女。