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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 ACTG 362最初是一项随机、双盲、安慰剂对照试验，旨在测试接受HIV治疗后CD 4细胞大量增加的人是否应该继续服用阿奇霉素预防MAC感染。 数据和安全监测委员会（一个审查研究的独立委员会）研究了ACTG 362迄今为止的结果，发现在CD 4细胞增加到100以上的人中，发生MAC的风险非常低。 因此，研究小组决定要求参与者停止服用研究药物，除非他们的CD 4计数降至50个细胞以下，并继续接受研究随访约2.5年（直到2002年4月）。 本研究将不再评估阿奇霉素预防MAC感染的可能长期获益。 DSMB审查的结果表明，在未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判断阿奇霉素是否有益于预防T细胞增加超过100个细胞的人的MAC疾病。 因此，本研究的主要目的是观察长期服用HAART方案（高效抗逆转录病毒疗法）是否能继续预防艾滋病定义的并发症和严重的细菌感染。 血液中脂肪（胆固醇和甘油三酯）水平的增加在一些长期服用艾滋病毒药物的患者中已经观察到，并且可能与心脏病发作的风险增加有关。 本研究继续随访的次要目的是确定入组研究的受试者的心脏病发作和卒中发生率。 由于本研究中的受试者长期服用HIV药物（约一半服用阿奇霉素），继续研究可能有助于确定服用阿奇霉素是否会对研究受试者的心脏病发作和中风风险产生影响。