NCT00075231已完成2 期
A Randomized, Open-Label Study Exploring a Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects
Abbott1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2003年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.
研究概览
简要总结
The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age.
- •Subject is confirmed HIV positive and in the investigator's opinion requires antiretroviral (ARV) therapy.
- •Subject is naïve to HIV ARV therapy or has received < 7 days total of any HIV ARV therapy > 30 days prior to study drug administration.
- •Subject's HIV RNA is >= 1000 copies/mL at screening.
- •If sexually active, subject agrees to use safe sex practices to reduce risk of HIV transmission (e.g., male or female condom, vaginal dam, etc.).
- •If female, the results of a urine pregnancy test performed at screening and on Day 1/Baseline are both negative.
- •If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
- •A. Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
- •B. A vasectomized partner.
- •C. Total abstinence from sexual intercourse.
- •Subject is not breastfeeding.
- •Subject's vital signs, physical examination, and laboratory results do not exhibit evidence of acute illness.
- •Subject has a Karnofsky score greater than or equal to
- •Subject agrees not to take any drugs during the study, including over-the-counter medicines, vitamins, mineral supplements, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the investigator.
- •Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug.
- •Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
排除标准
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, lamivudine, zidovudine, efavirenz, or to any inert materials contained in the study drug formulations.
- •Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.
- •Subject is currently taking any drug (medicinal or herbal) that is contraindicated and/or not to be co-administered with any of the three study drugs as defined in the current locally approved prescribing information.
- •Subject has a history of drug and/or alcohol abuse or psychiatric illness that in the investigator's opinion could preclude compliance with the protocol.
- •Subject is receiving immunomodulatory agents, colony stimulating factor, bone marrow stimulants (e.g., erythropoietin [Procrit®, Epogen®] or filgrastim [Neupogen®]), ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents.
- •The TRUGENE HIV-1 resistance report indicates resistance or possible resistance to the study reverse transcriptase inhibitor(s) [RTI(s)] (efavirenz, lamivudine or zidovudine) OR the presence of any mutation in the protease gene leading to an amino acid substitution at the following loci: 8, 30, 32, 46, 47, 48, 50, 54, 82, 84, or 90 OR four or more mutations at the following loci: 10, 20, 24, 36, 53, 63, or
- •Screening laboratory analyses show any of the following abnormal laboratory results: Presence of Hepatitis B surface antigen (HBsAg); Hemoglobin <= 9.5 g/dL; Absolute neutrophil count <= 1000 cells/mL; Platelet count <= 50,000 per mL; ALT (SGPT) or AST (SGOT) >= 3.0 x Upper Limit of Normal (ULN); Fasting Triglycerides > 750 mg/dL; Fasting Cholesterol > 300 mg/dL; Creatinine >= 1.5 x Upper Limit of Normal (ULN); Fasting serum glucose > 126 mg/dL
- •Subject is taking a prescribed lipid lowering medication such as HMG-CoA Reductase Inhibitors (statin) or fibrate medications.
- •Subject has a history of diabetes mellitus.
- •Subject has received any investigational drug or vaccine within 30 days prior to study drug administration.
- •For any reason, subject is considered by the investigator to be an unsuitable candidate to participate in the study.
结局指标
主要结局
Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected SubjectsHIV InfectionHepatitis CNCT00121017Abbott200
已完成
4 期
Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen FailureHIVAIDSLopinavirTreatment FailureNCT01189695Bamrasnaradura Infectious Diseases Institute63
已完成
3 期
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)Human Immunodeficiency Virus InfectionNCT00711009Abbott206
已完成
2 期
Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons With Drug ResistanceHIV InfectionsNCT00046033National Institute of Allergy and Infectious Diseases (NIAID)118
进行中（未招募）
1 期
A Randomized, Open-label, Study of Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once-Daily Versus Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Raltegravir 400 mg Twice-Daily in Antiretroviral-Naïve, HIV-1 Infected SubjectsTreatment-naïve, HIV-1 infected subjectsMedDRA version: 9.1Level: LLTClassification code 10020162Term: HIV infection CDC Group IEUCTR2008-000881-22-FRAbbott GmbH & Co. KG200