DOT-HAART for HIV-Infected South African Adults

针对感染艾滋病毒的南非成年人的 DOT-HAART

• 批准号: 6696670
• 负责人: Richard E. Chaisson
• 金额: $ 27.17万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6696670
• 关键词: 2'3' dideoxyinosine; AIDS therapy; African; HIV infections; adult human (21+); antiviral agents; behavioral /social science research tag; clinical research; combination chemotherapy; community health services; drug resistance; efavirenz; human subject; human therapy evaluation; lamivudine; medically underserved population; opportunistic infections; pathologic process; patient oriented research; peer group; self medication; social support network; therapy compliance; virus load

DESCRIPTION (provided by applicant): The primary objective of this study is to evaluate the effectiveness and feasibility of directly observed therapy (DOT) using patient-nominated peer supervisors as a strategy to improve adherence to highly active antiretroviral therapy (HAART) in HIV-infected adults in South Africa. This country has the worst and fastest growing HIV epidemic in the world. The benefit of HAART has been shown both at the individual and public health levels by reducing morbidity, mortality, vertical and possibly horizontal HIV transmission. However expenses, feasibility, long-term adherence and effective delivery of HAART remain formidable barriers, even in the healthier nations. Recently, international initiatives have provided hope for widespread use of HAART in sub-Saharan Africa at affordable cost. In addition, simplified (once daily) HAART combinations regimens with DOT may help to achieve high levels of treatment adherence, a key component for long-term viral suppression, and hence treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. In order to investigate the potential utility of Peer-DOT-HAART regimens in South Africa, we propose to conduct a randomized trial in which 200 patients will be randomized to either Peer-DOT-HAART or self-administration of a once-daily combination of didanosine, lamivudine, and efavirenz for 24 months. The specific aims of this study are: 1) to evaluate the impact of Peer-DOT-HAART on control of viral burden and immune restoration as measured by CD4 lymphocytes count and HIV viral load; 2) to evaluate the impact of DOT-HAART on treatment adherence; 3) to determine the proportion of genotypic HAART resistance in the DOT vs. self-administered HAART arms; 4) to compare incidence of new or recurrent opportunistic infection in the DOT vs. self-administered HAART. We hypothesize that the patients on the once daily observed regimen will have high levels of treatment adherence and hence more effective in controlling viral burden, thereby limiting the likelihood of virologic failure, drug resistance, and disease progression. This study will generate critical data on an alternative community-based approach of delivering HAART which may become a standard of care applicable throughout sub-Saharan Africa and the whole developing world.

描述（由申请人提供）：本研究的主要目的是使用患者提名的同伴主管评估直接观察到治疗（DOT）的有效性和可行性，以提高对HIV-高度活性抗逆转录病毒疗法（HAART）的依从性的策略。南非感染的成年人。这个国家拥有世界上最糟糕，增长最快的艾滋病毒流行病。通过降低发病率，死亡率，垂直和可能的水平HIV传播，HAART在个人和公共卫生水平上的好处均显示出来。然而，即使在更健康的国家，费用，可行性，长期依从性和有效的HAART也仍然是巨大的障碍。最近，国际倡议为在撒哈拉以南非洲以可承受的成本而广泛使用Haart的倡议为人们提供了希望。此外，简化（每天一次）与DOT的HAART组合方案可能有助于实现高水平的治疗依从性，长期病毒抑制的关键组成部分，从而成功。同伴倡导者已被用来提高各种环境中医疗疗法的依从性。为了调查南非同伴 - 哈特方案的潜在效用Didanosine，Lamivudine和Efavirenz持续了24个月。这项研究的具体目的是：1）评估同伴 - 点 - 通过CD4淋巴细胞计数和HIV病毒载量测量的同伴点对控制病毒负担和免疫恢复的影响； 2）评估点 - 哈特对治疗依从性的影响； 3）确定在DOT与自我管理的Haart Arms中基因型HAART抗性的比例； 4）比较在DOT与自我管理的HAART中新的或经常发生的机会感染的发生率。我们假设每天观察到的治疗方案的患者将具有很高的治疗依从性，因此在控制病毒负担方面更有效，从而限制了病毒学衰竭，耐药性和疾病进展的可能性。这项研究将对提供HAART的替代方法生成关键数据，该方法可能会成为整个撒哈拉以南非洲和整个发展中国家的护理标准。