EUCTR2005-001895-11-BE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-05
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Provide written informed consent and assess whether the subject is capable of reading and comprehending the informed consent;
- •2) Qualifying plasma HIV RNA = 5000 c/mL obtained at screening;
- •3) Men and women, ages 18 years and older (or minimum age as determined by local regulatory or as legal requirements dictate).
- •4) Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized. Both females and males must utilize effective barrier contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
- •2) WOCBP using a prohibited contraceptive method (see Protocol Appendix 8);
- •3) Women who are pregnant or breastfeeding;
- •4) Women with a positive pregnancy test on enrollment or prior to study drug administration;
- •5) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
- •6) Suspected primary (acute) HIV infection;
- •7) Any antiretroviral therapy within 30 days prior to screening
- •8) Prior antiretroviral therapy = 1 week. In the specific setting of antiretroviral treatment for reduction of risk of mother-to-child transmission, the following criteria will apply:
- •= 6 weeks of triple antiretroviral therapy (3 drugs of any class)
- •= 4 weeks of dual antiretroviral therapy (2 drugs of any class)
- •= 1 week of mono-antiretroviral therapy (1 drug of any class)
- •9) Subjects with Cushing’s syndrome;
- •10) Untreated hypothyroidism or hyperthyroidism;
- •11) Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4 (see Protocol Section 6.4 and Appendix 8);
- •12) Subjects with obstructive liver disease;
- •13) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
- •14) Proven or suspected acute hepatitis in the 30 days prior to study entry;
- •15) Intractable diarrhea (= 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;
- •16) Inability to swallow capsules;
- •17) Active peripheral neuropathy;
- •18) Presence of cardiomyopathy or any significant cardiovascular disease;
- •19) Known, clinically significant cardiac conduction system disease. This includes severe first degree atrioventricular block (PR interval > 0.26 seconds) as well as second and third-degree atrioventricular block;
- •20) Moderate to Severe hepatic insufficiency (screening Child-Pugh Score > 6 (Classes B or C)) (see Protocol Appendix 13);
- •21) Screening laboratory values measured as follows;:
- •a) Calculated creatinine clearance < 60 mL/min as estimated by the Cockcroft-Gault equation:
- •For men, (140 – age in years) x (body weight in kg) ÷ (serum
- •creatinine in mg/dL x 72) = CrCl (mL/min)
- •For women, multiply the result by 0.85
- •b) total serum lipase = 1.4 times the upper limit of normal,
- •c) liver enzymes (AST, ALT) = 5 times the upper limit of normal,
- •d) total serum bilirubin = 1.5 times the upper limit of normal.
- •22) Hypersensitivity to any component of the formulation of study drug;
- •23) Prohibited therapies and/or medication (see Protocol Appendix 8);
- •24) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements;
- •25) Prisoners or subjects who are compulsorily detained.
研究者
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