ACTG A5068: WITHDRAWL OF ANTIRETROVIRALS + HIV VACCINE IN SUBJECTS W/ CD4>400

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是看看短期停止抗艾滋病毒药物或在正在服用的抗艾滋病毒药物中添加疫苗是否有助于更好地控制艾滋病毒感染。这项研究将测试该疫苗在艾滋病毒感染者身上使用是否安全。这项研究还将测试短期停止抗艾滋病毒药物是否安全。艾滋病毒的长期控制有赖于个人免疫系统的改善。这项研究将测试偶尔停用抗艾滋病毒药物是否有这种效果。它将把这些结果与添加艾滋病毒疫苗ALVAC vCP1452获得的结果进行比较。这种艾滋病毒疫苗已经在没有感染艾滋病毒的人身上进行了测试，并改善了他们的免疫系统工作方式。这项研究将测试艾滋病病毒携带者是否会发生同样的免疫系统变化。如果这些变化真的发生了，这项研究还将测试这些变化是否有助于改善对艾滋病毒在体内的控制。这是一项为期约两年的第一阶段和第二阶段研究(一项检查有效性并寻找副作用的研究)。进入研究的患者将继续接受他们的抗艾滋病毒药物(不是由研究提供的)。患者将被随机分配到4个治疗组中的1个，如下：A组：疫苗安慰剂(不含疫苗的灭活溶液)和抗HIV药物治疗92周，1个疗程为12-20周。B组：疫苗安慰剂和抗HIV药物84周，其中1个停药周期为4~6周，1个停药周期为4周，1个停药周期为12~20周。C组：研究疫苗(VCP1452)联合抗HIV药物治疗92周，停药1次，疗程12~20周。D组：研究疫苗(VCP1452)和抗HIV药物84周，其中1个停药周期为4~6周，1个停药周期为4周，1个停药周期为12~20周。患者和他们的医生都不知道他们是否接受了研究疫苗或安慰剂。一半的患者将停用抗HIV药物2次，为期4-6周。所有患者在研究约一年后将停用抗HIV药物12-20周。这项研究有几个不同的步骤(总共8个)。并非所有步骤都适用于所有4组。在研究的第一年，所有患者将经常返回诊所，而在第二年，复诊的频率较低。在诊所就诊时，将进行简短的体检和病史，并采集血样以跟踪病毒载量和CD4计数。在其中9次检查中，将给予疫苗或疫苗安慰剂注射。

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. The purpose of this study is to see if either stopping anti-HIV drugs for short periods of time or adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection. The study will test whether the vaccine is safe to use in people with HIV infection. The study will also test whether stopping anti-HIV medicines for short periods of time is safe. Long-term control of HIV depends on improvement in an individual's immune system. This study will test whether occasionally stopping anti-HIV drugs has that effect. It will compare those results to those obtained by adding the HIV vaccine, ALVAC vCP1452. This HIV vaccine has been tested in people who did not have HIV infection and improved the way their immune system worked. This study will test whether these same immune system changes happen in people with HIV. If the changes do occur, the study will also test whether these changes help to improve control of HIV in the body. This is a Phase I and Phase II study (a study that examines effectiveness and looks for side effects) lasting about 2 years. Patients who enter the study will continue receiving their anti-HIV drugs (not provided by the study). Patients will be assigned randomly (like tossing a coin) to 1 of 4 treatment groups as follows: Group A: Vaccine placebo (an inactive solution with no vaccine) and anti-HIV drugs for 92 weeks with 1 therapy withdrawal period of 12-20 weeks. Group B: Vaccine placebo and anti-HIV drugs for 84 weeks with 1 therapy withdrawal period of 4-6 weeks, a 4-week therapy withdrawal period, and 1 therapy withdrawal period of 12-20 weeks. Group C: Study vaccine (vCP1452) and anti-HIV drugs for 92 weeks with 1 therapy withdrawal period of 12-20 weeks. Group D: Study vaccine (vCP1452) and anti-HIV drugs for 84 weeks with 1 therapy withdrawal period of 4-6 weeks, a 4-week therapy withdrawal period, and 1 therapy withdrawal period of 12-20 weeks. Neither the patients nor their doctors will know if they receive the study vaccine or placebo. Half of the patients will stop their anti-HIV drugs 2 times for a period of 4-6 weeks. All patients will stop their anti-HIV drugs for 12-20 weeks after about 1 year on the study. The study has a number of different steps (8 in all). Not all steps apply to all 4 groups. All patients will return to the clinic frequently for the first year of the study and less frequently for follow-up visits during the second year. At clinic visits a short physical exam and medical history will be done and blood samples will be collected to follow viral load and CD4 counts. At 9 of these visits, vaccine or vaccine placebo injections will be given.