PER-007-05已完成未知
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO DETERMINE THE RANGE OF DOSE TO COMPARE THE SAFETY AND ACTIVITY OF L-000900612 PLUS TENOFOVIR AND LAMIVUDINE (3TC) COMPARED TO EFAVIRENZ PLUS TENOFOVIR AND LAMIVUDINE (3TC) IN PATIENTS INFECTED WITH HIV NOT SUBMITTED A ART
MERCK & CO.INC.,0 个研究点目标入组 0 人开始时间: 2005年4月6日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •a. The patient is a man or woman 18 years of age or older.
- •b. The patient is HIV positive
- •c. The patient has a CD4 cell count, at the time of selection,> 100 cells / mm3
- •d. The patient has not been subjected to antiretroviral therapy (ART)
- •e. The patient had normal laboratory values within 21 days prior to the treatment phase of the present study
- •f. The patient has a chest x-ray without signs of active lung disease within 21 days prior to treatment
- •g. The patient does not wish to receive any other antiretroviral therapy for the duration of this study
- •h. The patient, who is potentially reproductive, agrees to use a method of birth control throughout the study.
排除标准
- •a. The female patient is pregnant or breastfeeding
- •b. The patient has received approved or experimental antiretroviral agents in the past
- •c. The patient has used immunological therapy agents, immunosuppressive therapy and / or agents under investigation within the month prior to treatment
- •d. The patient has been treated with adefovir or lamivudine for another viral infection.
- •e. The patient needs, or is anticipated to need, chronic daily prescription medications
- •f. The patient needs, or is anticipated to need, some prohibited medication
- •g. Significant hypersensitivity or other contraindication to any of the components of study drugs
- •h. The patient has documented resistance to tenofovir, lamivudine, and / or efavirenz.
- •i. The patient has a history of renal or urinary obstructive disease, or a calculated creatinine clearance, at the time of selection, <80 ml / min
- •j. The patient has a diagnosis of acute hepatitis due to any cause.
- •k. The patient has a history of Hepatitis C or a positive Hepatitis C serology.
- •l. The patient has Hepatitis B surface antigen.
- •m. The patient has a history of chronic abnormalities (> 1 month) in liver function tests
- •n. The patient has a history of alcohol or other substance abuse
- •or. The patient has some condition, pre-study laboratory abnormality or a history of some disease, which in the opinion of the investigator, could confuse the results of the study or pose an additional risk to the administration of the study drugs to the patient.
研究者
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