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

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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 Based on unpublished data from PACTG 381, only 54% of adolescents receiving highly active antiretroviral therapy (HAART) had undetectable viral loads at 16 weeks.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.