Long-Acting HIV Therapy for Injection Drug Users

针对注射吸毒者的长效艾滋病毒治疗

基本信息

批准号：
8425102
负责人：
JEFFREY M. JACOBSON
金额：
$ 64.5万
依托单位：
DREXEL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-04-01 至 2015-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8425102
关键词：
AIDS/HIV problem Adherence Alcohols Anti-Retroviral Agents Antibodies CCR5 gene Caring Chronic Disease Communities Controlled Clinical Trials Counseling Development Directly Observed Therapy Disease Doctor of Medicine Dose Double-Blind Method Drops Drug Delivery Systems Drug abuse Drug resistance Drug usage Drug user Ensure Epidemic Face Failure Generations HIV HIV Infections HIV therapy Health Services Accessibility Highly Active Antiretroviral Therapy Illicit Drugs Individual Infection Injecting drug user Intervention Intravenous Intravenous infusion procedures Life Life Expectancy Medicine Mental Depression Monitor Monoclonal Antibodies Morbidity - disease rate NIH Program Announcements National Institute of Drug Abuse Oral Oral Medicine PRO 140 Patients Perception Pharmaceutical Preparations Pilot Projects Placebo Control Population Principal Investigator Race Randomized Regimen Research Research Personnel Risk Self Efficacy Socioeconomic Status Subgroup Testing Treatment Protocols United States Vertical Disease Transmission Viral Viral Load result Viremia Virus Vulnerable Populations antiretroviral therapy base compliance behavior immune function improved innovation mortality novel open label oral care placebo controlled study programs public health relevance response subcutaneous success transmission process treatment duration treatment strategy

AIDS/HIV problem Adherence Alcohols Anti-Retroviral Agents Antibodies CCR5 gene Caring Chronic Disease Communities Controlled Clinical Trials Counseling Development Directly Observed Therapy Disease Doctor of Medicine Dose Double-Blind Method Drops Drug Delivery Systems Drug abuse Drug resistance Drug usage Drug user Ensure Epidemic Face Failure Generations HIV HIV Infections HIV therapy Health Services Accessibility Highly Active Antiretroviral Therapy Illicit Drugs Individual Infection Injecting drug user Intervention Intravenous Intravenous infusion procedures Life Life Expectancy Medicine Mental Depression Monitor Monoclonal Antibodies Morbidity - disease rate NIH Program Announcements National Institute of Drug Abuse Oral Oral Medicine PRO 140 Patients Perception Pharmaceutical Preparations Pilot Projects Placebo Control Population Principal Investigator Race Randomized Regimen Research Research Personnel Risk Self Efficacy Socioeconomic Status Subgroup Testing Treatment Protocols United States Vertical Disease Transmission Viral Viral Load result Viremia Virus Vulnerable Populations antiretroviral therapy base compliance behavior immune function improved innovation mortality novel open label oral care placebo controlled study programs public health relevance response subcutaneous success transmission process treatment duration treatment strategy

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项目摘要

DESCRIPTION (provided by applicant): Combination antiretroviral therapy has provided many HIV-infected individuals with a near-normal life expectancy, provided they have access to care and can maintain strict lifetime adherence to the daily or more frequent treatment regimens. The most important factor in the virologic failure of an antiretroviral regimen is poor adherence of the patient to complete and proper dosing. HIV-infected IDUs face well-documented challenges to maintaining optimal adherence. Accordingly, this group, which represents approximately one- quarter of the U.S. HIV epidemic, has yet to derive the full benefits of the available antiretroviral therapies. Various interventions to improve antiretroviral drug adherence, ranging from counseling to directly-observed therapy and other structural interventions, have had only modest success. We propose a novel treatment strategy involving systemic administration of long-acting antiretroviral therapy as a means to ensure effective drug delivery and viral suppression in HIV-infected populations prone to poor drug-adherence. We propose a randomized, double-blind, placebo-controlled study of weekly subcutaneous treatment with the CCR5 monoclonal antibody PRO 140 in combination with a standard-of-care oral antiretroviral regimen. PRO 140 is uniquely suited for this use as it is the only HIV drug to demonstrate long-acting viral suppression without the need for slow IV infusion. Success in this pilot study would identify a new strategy for improving the care of HIV-infected IDUs and other vulnerable populations that are underserved by the current generation of antiretroviral medications. Positive results could catalyze this field and spur development and testing of other long-acting HIV drugs in this population.

描述（由申请人提供）：抗逆转录病毒疗法的组合为许多受HIV感染的人提供了几乎正常的预期寿命，只要他们可以获得护理并可以维持严格的终生遵守日常或更频繁的治疗方案。抗逆转录病毒治疗方案病毒学衰竭的最重要因素是患者依从性完成和适当的给药。艾滋病毒感染的IDU面临着有充分记录的挑战，以维持最佳依从性。因此，该群体代表美国艾滋病毒流行的大约四分之一，尚未获得可用抗逆转录病毒疗法的全部益处。各种干预措施以改善抗逆转录病毒药物依从性，从咨询到直接观察的疗法和其他结构干预措施，仅取得了适度的成功。我们提出了一种新的治疗策略，涉及长效抗逆转录病毒疗法的系统性给药，以确保在容易发生药物遵守性不佳的HIV感染人群中有效递送药物和病毒抑制。我们提出了一项随机，双盲的，安慰剂对照的研究，每周使用CCR5单克隆抗体Pro 140与护理标准的口服抗逆转录病毒方案结合使用。 Pro 140非常适合此用途，因为它是唯一一种不需要缓慢静脉输注而表现出长效病毒抑制的HIV药物。这项试点研究的成功将确定一种新的策略，以改善受HIV感染的IDU和其他因当前一代抗逆转录病毒药物而服务不足的脆弱人群的护理。积极的结果可以催化这一领域，并刺激该人群中其他长效HIV药物的发展和测试。