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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心机构，不一定为研究者机构。最近被诊断出感染人体免疫机能丧失病毒（艾滋病毒）的青少年是一个特定的群体，由于他们的年龄，他们很可能在过去几年内受到感染。通常，他们不愿意参与正在进行的医疗护理，并且不太可能比成年人遵循医疗预约和坚持服药时间表。根据PACTG 381未发表的数据，只有54%的接受高效抗逆转录病毒治疗（HAART）的青少年在16周时病毒载量检测不到。尽管大多数受试者入组的研究中心通过青少年倡议获得了额外资金，以提高其招募和留住青少年参与临床试验的能力，但仍出现了这些令人失望的结果。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，建议病毒载量大于100，000拷贝/ml和/或CD 4计数小于350的个体进行治疗。这使得不符合治疗条件的青少年可以推迟治疗。延迟治疗的优点包括在患者开始治疗时有机会进行干预，从而提高依从性。治疗方案提高青少年的依从性（TREAT）是一个以预防为重点的多方面计划，以促进长期坚持HAART。该计划是基于改变的阶段（SOC）由Prochaska和DiClemente设计的行为改变模型（Prochaska和DiClemente，1986）。在这个模型中，个体在采取一种新的行为时，会循环地经历一系列阶段（预先考虑、考虑、准备、行动和维持）。TREAT包括对青少年进行分期，并针对每个阶段的变化准备情况，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）开发的材料，在治疗计划主要是为治疗初治艾滋病毒感染的青年，并努力准备他们成功地开始长期坚持HAART通过一个密集的八周计划。TREAT计划包括一本临床医生指导手册、两盘录像带、一本信息手册和一套五盘青少年录音带。青少年阶段使用标准的问卷调查，然后提供相应的干预该阶段。在每次门诊访视时重新分期。诊所的工作人员与每个年轻人单独工作，以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。将TREAT作为PACTG 381的任选组分并入。然而，PACTG 381没有收集关于TREAT干预是否由特定研究中心或个体患者使用的信息。P1034小组建议使用编写的TREAT或修改版本。两个相对简单的HAART方案，包括两个NRTI的青少年谁需要治疗将进行比较。我们将比较含PI（每日两次洛匹那韦/利托那韦（Kaletra））和PI保留（每日依法韦仑（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 Based on unpublished data from PACTG 381, only 54% of adolescents receiving highly active antiretroviral therapy (HAART) had undetectable viral loads at 16 weeks.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.