A PHASE III, RANDOMIZED, OPEN-LABEL, COMPARISON OF LOPINAVIR/RITONAVIR PLUS E

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。研究程序将包括艾滋病毒阳性受试者在至少96周或长达138周的时间内参加总共17次访问，这取决于受试者何时加入。将有一个筛选访问和入学前访问，以确定是否有资格学习。在本次访问中，将完成以下工作：询问病史和受试者目前正在服用的药物信息；受试者将被问及他/她可能出现的任何体征或症状；体格检查，包括记录血压、脉搏、呼吸、体温、身高和体重；抽血进行各种实验室检查；如果受试者是一名能够怀孕的女性，她将提供尿液样本或额外抽取1茶匙血液进行妊娠试验。孕妇不允许参与这项研究。步骤1。如果患者符合条件，他/她将随机接受：a)洛匹那韦/利托那韦(LPV/r) +斯塔夫定缓释（d4T XR）（或齐多夫定[ZVD]）+拉米夫定（3TC）；b)依非韦伦(EFV) +司他夫定（drT XR）或齐多夫定(ZDV) +拉米夫定（3TC），或；c)洛匹那韦/利托那韦(LPV/r) +依非韦伦（EFV）。第二步。如果受试者对治疗方案的一个组成部分出现毒性，他们将被随机分配到第二步；建议在同一类药物内进行药物替代。第三步。如果受试者出现病毒学失败，对第一步方案的一个以上组成部分出现毒性，或对第二步方案的一个组成部分出现毒性，他们将根据耐药性测试转到推荐的第二方案。在入组时将进行一次访问，在此期间将进行以下工作：将询问受试者是否有任何药物变化以及受试者可能出现的任何症状；如果受试者是女性，她将被问及一些妇科状况问题；全面体检，包括测量受试者生命体征；进行简单的身体检查，并测量腰围和臀部；抽血化验；受试者将被要求完成几份关于身体比例和他/她可能有的任何症状的简短问卷。受试者将进行全身双能x射线吸收扫描（DEXA）（骨骼和脂肪扫描）。

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 study procedures will consists of HIV-positive subjects taking part in a total of 17 visits over a period of at least 96 weeks or as long as 138 weeks depending on when subject joins. There will be a screening visit and a pre-entry visit to determine eligibility for study. At this visit, the following will be done: taking medical history and information regarding medications subject is currently taking; subject will be asked about any signs or symptoms he/she may have; a physical examination, including a recording of blood pressure, pulse, respiration, temperature, height, and weight; blood will be drawn for various laboratory tests; if subject is a woman able to become pregnant, either she will give a urine specimen or an additional 1 teaspoon of blood will be drawn for a pregnancy test. Pregnant women are not allowed in this study. Step 1. If a patient is eligible, he/she will be randomized to receive: a) Lopinavir/Ritonavir (LPV/r) + Stavdine extended release (d4T XR) (or zidovudine [ZVD])+Lamivudine (3TC); b) Efavirenz (EFV) + Stavudine (drT XR) or Zidovudine (ZDV) + Lamivudine (3TC), or; c) Lopinavir/Ritonavir (LPV/r) + Efavirenz (EFV). Step II. If subjects experience toxicity to one component of the regimen, they will be randomized to Step II; drug substitutions within the same class of drugs will be recommended. Step III. If subjects experience virologic failure, experience toxicity to more than one component of the step I regimen, or experience toxicities to one component of the step II regimen, they will be switched to a recommended second regimen based on resistance testing. At entry a visit will be conducted, at which time the following will be performed: subject will be asked about any medicine changes as well as any symptoms subject may have; if subject is a woman, she will be asked some gynecological status questions; a complete physical examination, including measuring subjects' vital signs; a brief physical examination and waist and hips will be measured; blood will be drawn for laboratory tests; subject will be asked to complete several short questionnaires about body proportions and any symptoms he/she may have. Subject will have a whole-body, dual-energy x-ray absorption (DEXA) scan (bone and fat scan).