P1034 (VERSION 10) A COMPARATIVE TRIAL OF PROTEASE-CONTAINING AND PROTEASE-S

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。最近被诊断为人类免疫缺陷病毒(艾滋病毒)的青少年是经过选择的人群，由于他们的年龄，他们很可能在过去几年内感染了艾滋病毒。通常，他们不愿进行持续的医疗护理，而且比成年人更不可能坚持医疗预约和坚持服药时间表。根据PACTG 381未发表的数据，接受高效抗逆转录病毒治疗(HAART)的青少年中，只有54%在16周时检测不到病毒载量。尽管大多数受试者是在通过青少年倡议获得额外资金的地点登记的，但仍出现了这些令人失望的结果，以增强他们招募和留住青少年参加临床试验的能力。根据2005年国际艾滋病协会-美国小组(IAS-USA)修订的成人和青少年抗逆转录病毒治疗指南，建议对病毒载量超过100,000拷贝/毫升和/或CD4计数低于350的个人进行治疗。这使得没有资格接受治疗的青少年可以推迟治疗。推迟治疗的好处包括在患者开始治疗时有机会进行干预，以提高患者的依从性。增强青少年依从性的治疗方案(Treat)是一项以青少年为重点的多方面计划，旨在促进长期遵守HAART。该计划是基于普罗查斯卡和迪克莱门特设计的行为变化阶段(SOC)模型(普罗查斯卡和迪克莱门特，1986)。在这个模型中，个体采取一种新的行为时，会周期性地经历一系列阶段(预想、沉思、准备、行动和维持)。治疗包括对青少年进行分期，并对每个准备好应对变化的阶段进行量身定做，并采取适合该阶段的具体干预措施。青少年医学艾滋病毒/艾滋病研究网络(AMHARN)开发了用于治疗的材料。治疗计划主要是为治疗幼稚的艾滋病毒感染青少年而设计的，并努力为他们通过为期八周的强化计划成功地开始长期遵守HAART做好准备。治疗方案包括一份临床医生指导手册，两盘录像带，一本资料手册，以及一套五盘青少年录音带。青少年使用标准问卷进行分期，然后提供与该阶段相对应的干预措施。每次去诊所就诊时都会重演。诊所工作人员与每个青少年单独合作，确定干扰完全遵守的障碍，并帮助他们发展必要的技能，以促进成功的行为改变。Treat被合并为PACTG 381的一个可选组件。然而，PACTG 381没有收集关于治疗干预是由特定地点还是由个别患者使用的信息。P1034团队建议使用原样处理或修改后的版本。将对两种相对简单的HAART方案进行比较，其中包括需要治疗的青少年中的两种NRTI。我们将比较含有PI的方案(每天两次洛匹那韦/利托那韦(Kaletra))和保留PI的(每天Eefavirenz(Sustiva))方案。

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. Adolescents recently diagnosed with human immunodeficiency virus (HIV) represent a select population whom, by virtue of their age, are likely to have been infected within the last few years. Frequently, they are reluctant to engage in ongoing medical care and are less likely than adults to follow through with medical appointments and to adhere to medication schedules. Based on unpublished data from PACTG 381, only 54% of adolescents receiving highly active antiretroviral therapy (HAART) had undetectable viral loads at 16 weeks. These disappointing results occurred despite the fact that the majority of subjects were enrolled at sites that had received additional funds through the adolescent initiative to enhance their ability to recruit and retain adolescents on clinical trials. According to the 2005 International AIDS Society-USA Panel (IAS-USA) revised guidelines for initiating antiretroviral therapy in adults and adolescents, therapy is recommended for individuals with a viral load of greater than 100,000 copies/ml and/or CD4 counts less than 350. This allows for the deferral of therapy in adolescents who do not qualify for treatment. Advantages to delaying therapy include opportunities for interventions that may improve adherence when the patients begin treatment. Therapeutic Regimens Enhancing Adherence in Teens (TREAT) is an adolescent-focused, multifaceted program to promote long-term adherence to HAART. The program is based on the Stages of Change (SOC) Model of behavior change designed by Prochaska and DiClemente (Prochaska and DiClemente, 1986). In this model, individuals move cyclically through a series of stages (precontemplation, contemplation, preparation, action, and maintenance) as they adopt a new behavior. TREAT consists of staging the adolescent and tailoring each stage of readiness for change with a specific intervention appropriate to that stage. The Adolescent Medicine HIV/AIDS Research Network (AMHARN) developed the materials used in TREAT. The TREAT program is designed primarily for treatment naive HIV infected youth, and strives to prepare them for the successful initiation of long-term adherence to HAART through an intensive eight-week program. The TREAT program includes a guidance manual for clinicians, two videotapes, an information booklet, and a set of five audiotapes for the adolescent. Adolescents are staged using a standard questionnaire and then offered the intervention corresponding to that stage. They are re-staged at every clinic visit. The clinic staff works individually with each youth to determine the obstacles that interfere with full adherence and help them develop the necessary skills to promote a successful behavior change. TREAT was incorporated as an optional component of PACTG 381. However, PACTG 381 did not collect information on whether the TREAT intervention was utilized by specific sites or by individual patients. The use of TREAT as it is written or a modified version is recommended by the P1034 team. Two relatively simple HAART regimens to include two NRTIs in adolescents who require therapy will be compared. We will compare a PI-containing (twice-daily lopinavir/ritonavir (Kaletra)) and a PI-sparing (daily efavirenz (Sustiva)) regimen.