ACTG 362-METAB,CARDIOVAS&NEUROLCOMPLICA'S IN SUBJ'S W/PAST CD4 CELL

ACTG 362-METAB，卡迪瓦斯

• 批准号: 7719416
• 负责人: THOMAS A CAMPBELL
• 金额: $ 0.44万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719416
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Azithromycin; Bacterial Infections; Blood; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; Cells; Cholesterol; Clinical Trials Data Monitoring Committees; Computer Retrieval of Information on Scientific Projects Database; Disease; Drops; Enrollment; Fatty acid glycerol esters; Funding; Grant; HIV; Highly Active Antiretroviral Therapy; Infection; Institution; Link; Myocardial Infarction; Participant; Patients; Pharmaceutical Preparations; Prevention; Prophylactic treatment; Purpose; Randomized; Rate; Research; Research Personnel; Resources; Risk; Source; Stroke; Study Subject; T-Lymphocyte; Testing; Time; Treatment Protocols; Triglycerides; United States National Institutes of Health; design; double-blind placebo controlled trial; prevent

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. ACTG 362 started as a randomized, double-blind, placebo-controlled trial designed to test whether people who had large increases in CD4 cells with HIV treatment should continue to take azithromycin prophylaxis to prevent MAC infection. The data and Safety Monitoring Board (an independent committee who reviews studies) looked at the results available so far from ACTG 362 and found that the risk of developing MAC is very low in people who have had increases to more than 100 CD4 cells. Therefore, the study team decided to ask participants to stop taking the study medications unless their CD4 counts have dropped below 50 cells and continue to be followed on study for approximately 2.5 years (until April 2002). The study will no longer evaluate the possible long-term benefit of azithromycin to prevent MAC infection. The results of the DSMB review suggest that the risk of MAC is so low in the subjects not taking the active drug azithromycin that it was unlikely the study would ever tell if there is a benefit of azithromycin for the prevention of MAC disease in people who have an increase in T cells above 100 cells. Therefore, the main purpose of this study now will be to see if taking a HAART regimen (highly active antiretroviral therapy) for a long period of time will continue to prevent AIDS defining complications and serious bacterial infections. Increased levels of fats (cholesterol and triglycerides) in the blood have been seen in some patients taking HIV drugs for a long time, and may be linked to possible increased risk of heart attacks. A secondary purpose of continuing to be followed on this study will be to determine the rates of heart attacks and strokes among subjects enrolled in the study. Because the subjects in this study have been on HIV medication (and about half have been on azithromycin) for a long time, continuing the study may help to determine if having taken azithromycin will have a effect on the risk of heart attacks and strokes among the study subjects.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 ACTG 362最初是作为一项随机，双盲的安慰剂对照试验，旨在测试接受HIV治疗的CD4细胞大量增加的人是否应继续采取阿奇霉素的预防症，以防止MAC感染。 数据和安全监测委员会（一个独立的委员会审查研究）研究了远离ACTG 362的结果，发现患有MAC的风险非常低，患者增加了100多个CD4细胞。 因此，研究团队决定要求参与者停止服用研究药物，除非他们的CD4计数已降至50个细胞以下并继续进行研究大约2。5年（直到2002年4月）。 该研究将不再评估阿奇霉素可能的长期益处，以防止MAC感染。 DSMB综述的结果表明，在不服用活性药物阿奇霉素的受试者中，MAC的风险如此之低，以至于该研究不太可能证明是否有阿奇霉素在预防T细胞升高的人中是否有促硫霉素的益处。 因此，这项研究的主要目的是查看长期服用HAART方案（高活性抗逆转录病毒疗法）是否会继续防止定义并发症和严重细菌感染的艾滋病。 在一些服用HIV药物的患者长期以来，血液中脂肪（胆固醇和甘油三酸酯）的水平升高，可能与可能增加的心脏病发作风险有关。 继续遵循这项研究的次要目的是确定研究中入学的受试者之间的心脏病发作和中风的速度。 由于这项研究中的受试者长期以来一直使用HIV药物（大约一半是在阿奇霉素上），因此继续进行研究可能有助于确定是否服用了阿奇霉素，是否会影响研究对象中心脏病发作和中风的风险。