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：
8603231
负责人：
JEFFREY M. JACOBSON
金额：
$ 6.32万
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 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8603231
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

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）：联合抗逆转录病毒疗法为许多艾滋病毒感染者提供了接近正常的预期寿命，前提是他们能够获得护理，并且能够一生严格遵守每日或更频繁的治疗方案。抗逆转录病毒治疗方案病毒学失败的最重要因素是患者对完整和正确剂量的依从性差。感染艾滋病毒的注射吸毒者在保持最佳依从性方面面临着有据可查的挑战。因此，这一群体约占美国艾滋病毒流行的四分之一，尚未获得现有抗逆转录病毒疗法的全部益处。提高抗逆转录病毒药物依从性的各种干预措施，从咨询到直接观察治疗和其他结构性干预措施，仅取得了有限的成功。我们提出了一种新的治疗策略，涉及全身施用长效抗逆转录病毒疗法，作为确保药物依从性差的艾滋病毒感染人群有效药物输送和病毒抑制的手段。我们提出了一项随机、双盲、安慰剂对照研究，每周皮下注射 CCR5 单克隆抗体 PRO 140 并结合标准护理口服抗逆转录病毒疗法。 PRO 140 非常适合这种用途，因为它是唯一一种无需缓慢静脉输注就能发挥长效病毒抑制作用的 HIV 药物。这项试点研究的成功将确定一种新的策略，以改善对感染艾滋病毒的注射吸毒者和其他弱势群体的护理，而这些群体目前的抗逆转录病毒药物服务不足。积极的结果可能会促进这一领域的发展，并刺激其他长效艾滋病毒药物在该人群中的开发和测试。