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

洛匹那韦/利托那韦加 E 的 III 期、随机、开放标签比较

• 批准号: 7606178
• 负责人: ERIC S DAAR
• 金额: $ 0.13万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606178
• 关键词: Blood; Blood Pressure; Class; Computer Retrieval of Information on Scientific Projects Database; Eligibility Determination; Failure; Fatty acid glycerol esters; Funding; Grant; Height; Hip region structure; Institution; Label; Laboratories; Lamivudine; Lamivudine/Zidovudine; Lopinavir/Ritonavir; Measures; Medical History Taking; Medicine; Patient currently pregnant; Patients; Pharmaceutical Preparations; Phase; Physical Examination; Pregnancy Tests; Pregnant Women; Procedures; Pulse Pressure; Questionnaires; Randomized; Research; Research Personnel; Resistance; Resources; Respiration; Scanning; Screening procedure; Source; Specimen; Stavudine; Symptoms; Temperature; Testing; Time; Toxic effect; Treatment Protocols; United States National Institutes of Health; Urine; Visit; Week; Weight; Woman; Zidovudine; absorption; base; bone imaging; efavirenz; experience

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 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).

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。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 研究中心，而研究中心不一定是研究者所在的机构。 研究程序将包括受试者在至少96周或最长138周（取决于受试者加入的时间）内参加总共17次访视。将进行一次筛选访视和一次入组前访视，以确定是否有资格参加研究。在该访视时，将进行以下操作：采集病史和受试者当前正在服用的药物信息;询问受试者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;如果受试者是能够怀孕女性，她将提供尿液样本或额外抽取1茶匙血液进行妊娠试验。孕妇不允许参与本研究。 步骤1. 如果患者合格，他/她将随机接受：a）洛匹那韦/利托那韦（LPV/r）+司他夫定缓释剂（d4 T XR）（或齐多夫定[ZVD]）+拉米夫定（3 TC）; B）依法韦仑（EFV）+司他夫定（d4 T XR）或齐多夫定（ZDV）+拉米夫定（3 TC），或; c）洛匹那韦/利托那韦（LPV/r）+依法韦仑（EFV）。 步骤II.如果受试者对方案的一种组分发生毒性，则将其随机分配至步骤II;将建议在同一类药物中进行药物替代。 步骤III.如果受试者发生病毒学失败，对步骤I方案的一种以上组分发生毒性，或对步骤II方案的一种组分发生毒性，则将根据耐药性检测将其转换为推荐的第二种方案。 入组时将进行访视，此时将进行以下操作：询问受试者任何药物变化以及受试者可能出现的任何症状;如果受试者为女性，将询问其一些妇科状况问题;进行全面体格检查，包括测量受试者的生命体征;进行简短体格检查，并测量腰部和臀部;抽血进行实验室检查;将要求受试者完成几份关于身体比例和他/她可能具有的任何症状的简短问卷。 受试者将接受全身双能X射线吸收（DEXA）扫描（骨骼和脂肪扫描）。