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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 802
- 主要终点
- Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48
研究概览
简要总结
To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 positive
- •Naïve to antiretroviral therapy including investigational antiretroviral agents
- •Not of reproductive potential or, if of reproductive potential agrees to 1) true abstinence, or 2) use of an acceptable method of birth control during the study
排除标准
- •Use of recreational or illicit drugs or has recent history of drug or alcohol abuse or dependence
- •Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine
- •Has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir before the first dose of study drug
- •Has participated in a study with an investigational compound or device within 30 days or anticipates participating in such a study during this study
- •Has used systemic immunosuppressive therapy or immune modulators within 30 days or is anticipated to need them during the study (short courses of corticosteroids are allowed)
- •Requires or is anticipated to require any of the following prohibited medications while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium, magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of Magnesia™
- •Has significant hypersensitivity or other contraindication to any of the components of the study drugs
- •Has current, active diagnosis of acute hepatitis due to any cause
- •Is pregnant, breastfeeding, or expecting to conceive during the study
- •Female participant expecting to donate eggs or male participant expecting to donate sperm during the study
- •Is or has a family member (spouse or children) who is investigational staff or sponsor staff directly involved in this trial
研究组 & 干预措施
Reformulated Raltegravir
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
干预措施: Reformulated Raltegravir (Drug)
Reformulated Raltegravir
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
干预措施: TRUVADA™ (Drug)
Reformulated Raltegravir
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
干预措施: Placebo to Raltegravir (Drug)
Raltegravir
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
干预措施: Raltegravir (Drug)
Raltegravir
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
干预措施: TRUVADA™ (Drug)
Raltegravir
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
干预措施: Placebo to Reformulated Raltegravir (Drug)
结局指标
主要结局
Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48
时间窗: Week 48
From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
次要结局
- Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96(Week 96)
- Percentage of Participants With an AE After 96 Weeks of Treatment(Up to Week 98 (96 weeks of treatment + 2 weeks of follow up))
- Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment(Up to Week 98 (96 weeks of treatment + 2 weeks of follow up))
- Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48(Baseline and Week 48)
- Change From Baseline in CD4 Cell Count at Week 96(Baseline and Week 96)
- Percentage of Participants With an Adverse Event (AE) at Week 48(Up to Week 48)
- Percentage of Participants With a SAE After 96 Weeks of Treatment(Up to Week 98 (96 weeks of treatment + 2 weeks of follow up))
- Percentage of Participants With a Serious and Drug-Related AE at Week 48(Up to Week 48)
- Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment(Up to Week 98 (96 weeks of treatment + 2 weeks of follow up))
- Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48(Up to Week 48)
- Percentage of Participants With a Drug-Related AE at Week 48(Up to Week 48)
- Percentage of Participants With a Serious Adverse Event (SAE) at Week 48(Up to Week 48)
- Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96(Up to Week 96)