A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 8 人开始时间: 2014年10月6日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Male or female ≥ 18 years of age
•Understand and comply with study procedures, agree to participate by giving informed consent
•HIV-1 + determined by enzyme-immunoassay, have screening plasma HIV-1 RNA
•Naïve to antiretroviral therapy including investigational antiretroviral agents
•Have the following screening laboratory values:
•Serum creatinine ≤2.0 x ULN
•Alkaline phosphatase ≤3.0 x ULN
•AST (SGOT) and ALT (SGPT) ≤5.0 x ULN
•Has a creatinine clearance ≥ 30 mL/min at time of screening
•Be considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study
•Agree to one of the following if of reproductive potential :
•True abstinence: Abstinence is in line with the preferred and usual lifestyle of the subject
•Use of an acceptable method of birth control throughout the study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy

•History or current condition, therapy, lab abnormality or other circumstance that might confound the results of the study
•User of recreational/illicit drugs or recent history of alcohol abuse
•Treated for a viral infection other than HIV-1, such as Hep B, with an agent active against HIV-1
•Known resistance to raltegravir, emtricitabine and/or tenofovir prior to treatment phase
•Participated in a study with an investigational compound/device within 30 days of signing informed consent or anticipates participating in a study involving it/them during the study.
•Used systemic immunosuppressive therapy or immune modulators within 30 days prior to study med or is anticipated to need them during the study
•Requires or will require prohibited med:
•Ca, Mg and Al containing antacids
•Inducers of CYP3A4, including phenobarbital, phenytoin, rifampin, or rifabutin.
•Hypersensitivity/contraindication to any component of study drugs
•Current diagnosis of acute hepatitis due to any cause. Chronic Hep B and C may enter if they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function
•Pregnant, breastfeeding, or expecting to conceive during the study.
•Female expecting to donate eggs or male expecting to donate sperm during the study
•Has immediate family member who is site or SPONSOR staff directly involved in this trial

发起方

MERCK SHARP & DOHME PERU S.R.L.,