PER-080-05已完成未知
STUDY OF 96 WEEKS OF DURATION COMPARING THE ANTIVIRAL EFFICACY AND SAFETY OF ATAZANAVIR / RITONAVIR WITH LOPINAVIR / RITONAVIR, EACH ONE COMBINED WITH FIXED DOSES OF TENOFOVIR-EMTRICITABIN, ADMINISTERED IN PATIENTS INFECTED WITH HIV-1 WHO ARE TREATMENT NAIVE
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1) Provide informed consent in writing, assess whether the patient is able to read and understand the content of informed consent.
- •2) Qualifying plasma level of HIV RNA> 5,000 c / ml.
- •3) Men and women over 18 years of age.
- •4) Women of childbearing age (FEM) should use a method of birth control that is appropriate.
- •5) Women of childbearing age must present a negative result in the pregnancy test performed in serum or urine.
排除标准
- •1) WFAs that are not willing or able to use a method of birth control that is acceptable.
- •2) The WFAs that are using a prohibited contraceptive method.
- •3) Pregnant or lactating women.
- •4) Women who have obtained a positive result in the pregnancy test.
- •5) Presence of newly diagnosed HIV-related opportunistic infection, or any clinical condition that requires acute therapy at the time of enrollment.
- •6) Suspected primary infection (acute) due to HIV.
- •7) Any antiretroviral therapy in the 30 days prior to selection.
- •8) Previous antiretroviral therapy for> 1 week.
- •9) Subjects with Cushing´s syndrome.
- •10) Untreated hypothyroidism or hyperthyroidism.
- •11) Recent therapy with drugs that have a significant myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential in the previous 3 months.
- •12) Subjects with obstructive liver disease.
- •13) Active abuse of alcohol or substances that is sufficient to prevent adequate compliance with the therapy under study, or may increase the risk of developing pancreatitis or drug hepatitis.
- •14) Acute hepatitis proven or suspected within 30 days prior to admission to the study.
- •15) Intractable diarrhea during the 30 days prior to admission to the study.
- •16) Impossibility of swallowing the capsules.
- •17) Active peripheral neuropathy.
- •18) Presence of cardiomyopathy or of any significant cardiovascular disease.
- •19) Clinically significant known disease of the cardiac conduction system.
- •20) Moderate to severe hepatic insufficiency.
- •21) Laboratory values not acceptable in the selection.
- •22) Hypersensitivity to any of the ingredients of the study medication formula.
- •23) Receive any of the prohibited therapies.
- •24) Any other clinical condition or previous therapy that would make the patient unfit to continue in the study, or unable to meet the requirements of the treatment.
- •25) Prisoners or subjects who are compulsorily arrested may not be enrolled in this study.
研究者
相似试验
进行中（未招募）
不适用
A retrospective study to compare the 3-year antiviral efficacy of nevirapine and efavirenz in combination with D4T and 3TC in 2NN patients - 2NN Follow-up studyTreatment of HIV-1 infectionEUCTR2004-000623-16-GBBoehringer Ingelheim Ltd750
进行中（未招募）
1 期
A retrospective study to compare the 3-year antiviral efficacy of nevirapine and efavirenz in combination with D4T and 3TC in 2NN patients - 2NN Follow-up studyTreatment of HIV-1 infectionEUCTR2004-000623-16-BEn.v. Boehringer Ingelheim s.a.750
进行中（未招募）
不适用
A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavirwith Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabinein HIV-1 Infected Treatment Naive Subjects.Revised Protocol 01: incorporates amendment 03.Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; andMetabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05EUCTR2005-001895-11-ATBristol-Myers Squibb International Corporation1,200
进行中（未招募）
1 期
A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavir with Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment Naive Subjects. Revised Protocol 04 Incorporating changes from Amendment 03, 04, 05, 06 (Version 1.0, Date 03-Apr-2007), and Administrative Letter dated 31-Oct-2006. Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; and Metabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05HIV-1 Infected Treatment Naive SubjectsEUCTR2005-001895-11-GBBristol-Myers Squibb International Corporation1,200
进行中（未招募）
1 期
A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavirwith Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabinein HIV-1 Infected Treatment Naive Subjects.Revised Protocol 01: Incorporates changes from Amendment 03.Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; andMetabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05HIV-1 Infected Treatment Naive SubjectsEUCTR2005-001895-11-BEBristol-Myers Squibb International Corporation1,200