Long-Acting HIV Therapy for Injection Drug Users

针对注射吸毒者的长效艾滋病毒治疗

• 批准号: 8054808
• 负责人: JEFFREY M. JACOBSON
• 金额: $ 71.58万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 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/8054808
• 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; Public Health; 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

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. PUBLIC HEALTH RELEVANCE: 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. HIV-infected injection drug users (IDUs) face well-documented challenges to maintaining optimal adherence. Accordingly, this group, which represents approximately one-quarter of the HIV epidemic in the United States, has yet to derive the full benefits of the available antiretroviral therapies. 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.

描述（由申请人提供）：联合抗逆转录病毒治疗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，并能够终身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适当剂量的依从性差。感染艾滋病毒的注射吸毒者在保持最佳依从性方面面临有据可查的挑战。因此，这一群体占美国艾滋病毒流行病的大约四分之一，尚未获得可用抗逆转录病毒疗法的全部益处。从咨询到直接观察治疗和其他结构性干预措施，提高抗逆转录病毒药物依从性的各种干预措施只取得了一定的成功。我们提出了一种新的治疗策略，涉及系统管理的长效抗逆转录病毒治疗的手段，以确保有效的药物输送和病毒抑制艾滋病毒感染人群中容易出现药物依从性差。我们提出了一项随机、双盲、安慰剂对照的研究，每周皮下注射CCR5单克隆抗体PRO 140联合标准的口服抗逆转录病毒治疗方案。PRO 140非常适合这种用途，因为它是唯一一种证明长效病毒抑制而无需缓慢静脉输注的HIV药物。这一试点研究的成功将确定一项新的战略，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，这些人得不到当前一代抗逆转录病毒药物的充分服务。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这一人群中的开发和测试。 公共卫生相关性：联合抗逆转录病毒疗法使许多艾滋病毒感染者的预期寿命接近正常，条件是他们能够获得护理，并能够终生严格遵守每日或更频繁的治疗方案。感染艾滋病毒的注射吸毒者在保持最佳依从性方面面临有据可查的挑战。因此，这一群体约占美国艾滋病毒流行病的四分之一，尚未从现有的抗逆转录病毒疗法中充分获益。我们提出了一种新的治疗策略，涉及系统管理的长效抗逆转录病毒治疗的手段，以确保有效的药物输送和病毒抑制艾滋病毒感染人群中容易出现药物依从性差。