EUCTR2008-002733-70-IT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 - ND
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
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
入选标准
- •Patient is a male or female at least 18 years of age on the day of signing the informed
- •2. Patient is HIV positive as determined by a positive result by enzyme-linked
- •immunosorbent assay (ELISA) and has screening plasma HIV RNA (determined by
- •the central laboratory) >5000 copies/mL within 45 days prior to the treatment phase
- •of this study, and is indicated for treatment based on physician assessment. Local
- •treatment guidelines should be considered in the decision to initiate therapy.
- •3. Patient is naive to antiretroviral therapy (ART) or defined as having received <7 days
- •total of any ART.
- •Patient has the following laboratory values within 45 days prior to the treatment
- •phase of this study:
- •4.1 Serum creatinine ≤2.0 x upper limit of normal
- •4.2 Alkaline phosphatase ≤5.0 x upper limit of normal
- •4.3 AST (SGOT) and ALT (SGPT) ≤5.0 x upper limit of normal
- •Note: A single repeat of a laboratory screening test will be allowed for test results that
- •are unexpected based on documented prior laboratory results.
- •5. Patient has a calculated creatinine clearance at time of screening >30 mL/min, based
- •on the Cockcroft-Gault equation which is as follows (and 0.85X this value for
- •Clcr (mL/min) = (140-age) x weight (in kg)
- •72 x serum creatinine (mg/dL)
- •6. In the opinion of the investigator, the patient should be considered clinically stable
- •with no signs or symptoms of active infection, at the time of entry into the study; i.e.,
- •clinical status and all chronic medications should be unchanged for at least 2 weeks
- •prior to the start of treatment in this study.
- •7. Patient who is of reproductive potential agrees remain abstinent or use (or have their
- •partner use) 2 acceptable methods of birth control throughout the study. Acceptable
- •methods of birth control are: oral contraceptives, intrauterine device (IUD),diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
- •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
- •Patient 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 patient?s participation for the full duration of the study, such that it
- •is not in the best interest of the patient to participate.
- •2. Patient is, at the time of signing informed consent, a user of recreational or illicit
- •drugs or has had a recent history (within the last year) of drug or alcohol abuse or
- •dependence.
- •3. Patient has been treated for a viral infection other than HIV, such as hepatitis B, with
- •an agent that is active against HIV including but not limited to adefovir, tenofovir,
- •emtricitabine or lamivudine.
- •Note: Patients may be enrolled if treatment occurred prior to the diagnosis of HIV.
- •4. Patient has documented resistance to tenofovir, emtricitabine, and/or efavirenz.
- •5. Patient is currently participating or has participated in a study with an investigational
- •compound or device within 45 days of signing informed consent.
- •6. Patient has used another experimental HIV-integrase inhibitor.
- •7. Patient has used systemic immunosuppressive therapy within one month prior to
- •treatment in this study. Short courses of corticosteroids (e.g., as for asthma
- •exacerbation) will be allowed.
- •8. Patient requires hemodialysis.
研究者
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