ACTG A5202

这个子项目是众多研究子项目之一

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. Current guidelines for the initial treatment of HIV-1 infection provide a number of options for patients and providers (available at http://www.aidsinfo.nih.gov/). There have been an ever-growing number of approved ARV agents and studies that demonstrate high levels of virologic success when employing potent, well-tolerated, and simple regimens. Of the Department of Health and Human Services (DHHS) preferred regimens, two nucleoside reverse transcriptase inhibitors (NRTIs) with the NNRTI EFV is the simplest combination to take and has had the highest overall success rates in randomized controlled trials done to date [1-3]. However, novel agents have recently been approved that provide simple once daily protease inhibitors (PIs) as well as once daily NRTI combinations with prolonged half-lives that may offer unique advantages over established therapies. As novel agents become available it is critical to assess their role in optimizing the management of HIV-1. This includes understanding the relative potency, tolerability, resistance patterns that emerge, and the consequent remaining treatment options if drug resistance occurs for newer regimens. This study will compare the use of RTV-enhanced ATV to EFV, in combination with either daily FTC/TDF or ABC/3TC, and of ABC/3TC compared to FTC/TDF in combination with either EFV or RTV-enhanced ATV as initial therapy for HIV-1 infection. Hypotheses RTV-enhanced ATV in combination with FTC/TDF is equivalent to EFV in combination with FTC/TDF with respect to antiviral potency. RTV-enhanced ATV in combination with ABC/3TC is equivalent to EFV in combination with ABC/3TC with respect to antiviral potency. EFV in combination with ABC/3TC is equivalent to EFV in combination with FTC/TDF with respect to antiviral potency. RTV-enhanced ATV in combination with ABC/3TC is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to antiviral potency. The primary objectives follow a pattern of comparing the study PI (RTV-enhanced ATV) with the study NNRTI (EFV) for each of the NRTI combinations; and the NRTI combinations with each other, when used with the study PI or the study NNRTI. These four comparisons are made for each of the three main objectives (efficacy, safety, and tolerability). To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level =1000 copies/mL at or after 16 weeks and before 24 weeks or =200 copies/mL at or after week 24. To compare the safety between regimens with safety defined as the time to first development of Grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline. To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen.