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

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。子项目及 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。 这项研究的目的是观察短期停用抗艾滋病毒药物或在正在服用的抗艾滋病毒药物中加入疫苗是否有助于更好地控制艾滋病毒感染。这项研究将测试这种疫苗在艾滋病毒感染者中使用是否安全。这项研究还将测试短期停用抗艾滋病毒药物是否安全。 艾滋病毒的长期控制取决于个人免疫系统的改善。这项研究将测试偶尔停止抗艾滋病毒药物是否有这种效果。它将这些结果与通过添加HIV疫苗ALVAC vCP 1452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，并改善了他们免疫系统的工作方式。这项研究将测试这些相同的免疫系统变化是否发生在艾滋病毒感染者身上。如果这些变化确实发生，该研究还将测试这些变化是否有助于改善体内艾滋病毒的控制。 这是一项I期和II期研究（一项检查有效性并寻找副作用的研究），持续约2年。入组研究的患者将继续接受抗HIV药物（研究未提供）。将患者随机分配（如掷硬币）至4个治疗组之一，如下所示： A组：疫苗安慰剂（一种无活性溶液，不含疫苗）和抗艾滋病毒药物治疗92周，其中1个停药期为12-20周。 B组：疫苗安慰剂和抗HIV药物治疗84周，其中1个停药期为4-6周，1个停药期为4周，1个停药期为12-20周。 C组：研究疫苗（vCP 1452）和抗HIV药物治疗92周，停药期为12-20周。 D组：研究疫苗（vCP 1452）和抗HIV药物治疗84周，包括1个4-6周停药期、1个4周停药期和1个12-20周停药期。 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。一半的患者将在4-6周的时间内停药2次。所有患者将在研究约1年后停用抗HIV药物12-20周。该研究有许多不同的步骤（共8个）。并非所有步骤都适用于所有4组。所有患者将在研究的第一年频繁返回诊所，而在第二年的随访访视中频率较低。在诊所访视时，将进行简短的体格检查和病史检查，并采集血液样本以跟踪病毒载量和CD 4计数。在其中9次访视时，将进行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.