PER-022-15已完成未知
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 32 人开始时间: 2015年8月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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
- 18 至 100（—）
- 性别
- All
入选标准
- •1 Be at least 18 years of age
- •2 Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial
- •3 Be HIV-1 positive as determined by a positive result on an enzyme-immunoassay, have screening plasma HIV-1 RNA ≥1000 copies/mL within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment
- •4 Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
- •5 Have the following laboratory values at screening: Alkaline phosphatase ≤3.0 x upper limit of normal; AST (SGOT) and ALT (SGPT) ≤5.0 x upper limit of normal
- •6 Have a calculated creatinine clearance at the time of screening ≥ 50 mL/min, based on the Cockcroft-Gault equation
- •7 In the opinion of the investigator, be considered clinically stable with no signs or symptoms of active infection at the time of entry into the study
- •8 Be highly unlikely to become pregnant or to impregnate a partner (Male or female who is not of reproductive potential or male or female who is of reproductive potential and agrees to use acceptable methods of contraception
排除标准
- •1 Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the
- •subject’s participation for the full duration of the study
- •2 Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
- •3 Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
- •4 Has documented or known resistance to study drugs
- •5 Has participated or will participate in a study with an investigational compound/device within 30 days
- •prior to signing informed consent or during the study
- •6 Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
- •7 Requires or is anticipated to require any of the prohibited medications noted in the protocol
- •8 Has significant hypersensitivity or other contraindication to any of the components of
- •the study drugs
- •9 Has a current (active) diagnosis of acute hepatitis due to any cause
- •10 Is pregnant, breastfeeding, or expecting to conceive
- •11 is female and is expecting to donate eggs or is male and
- •is expecting to donate sperm (at any time during the study)
- •12 is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
研究者
相似试验
进行中（未招募）
1 期
MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on MetformiType 2 Diabetes MellitusEUCTR2012-004035-23-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as240
进行中（未招募）
1 期
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518)Versus Twice Daily Raltegravir, Each in Combination With TRUVADA in Treatment-Naive HIV Infected Patients - NDEUCTR2008-002733-70-ITMERCK & CO., INC.700
进行中（未招募）
1 期
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected PatientsHIV infectionMedDRA version: 11 Level: PT Classification code 10020161 Term: <Manually entered code. Term in E.1.1>EUCTR2008-002733-70-FRaboratoires Merck Sharp & Dhome-Chibret750
进行中（未招募）
1 期
MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on MetformaiMedDRA version: 18.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2012-004035-23-GRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.90
已完成
3 期
A Study of the Safety and Efficacy of MK-0431A XR, a Fixed-Dose Combination Tablet of Sitagliptin and Extended-Release Metformin in Pediatric Participants aged 10-17 years With Type 2 Diabetes MellitusType 2 Diabetes MellitusSLCTR/2014/037Merck Sharp and Dohme Corp