NCT01489046终止2 期
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose
Bristol-Myers Squibb15 个研究点 分布在 2 个国家目标入组 297 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 297
- 试验地点
- 15
- 主要终点
- Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
研究概览
简要总结
The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects
详细描述
Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through 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
- Quadruple (Participant, Care Provider, 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
- •At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
- •Plasma HIV-1 RNA > 5000 copies/mL
- •Antiretroviral treatment-naive; defined as no current or previous exposure to > 1 week of an antiretroviral drug
- •CD4+ T-cell count > 200 cells/mm3
排除标准
- •Resistance to any of the study medications [Tenofovir Disoproxil Fumarate(TDF), Efavirenz (EFV), Lamivudine (3TC)] or to HIV Protease Inhibitors (PIs)
- •Contraindications to any of the study drugs
研究组 & 干预措施
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: Efavirenz (Drug)
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: BMS-986001 (Drug)
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: Placebo matching with BMS-986001 (Drug)
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: Lamivudine (Drug)
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: BMS-986001 (Drug)
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: Placebo matching with BMS-986001 (Drug)
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: Efavirenz (Drug)
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Experimental
干预措施: Lamivudine (Drug)
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Experimental
干预措施: BMS-986001 (Drug)
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Experimental
干预措施: Efavirenz (Drug)
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Experimental
干预措施: Lamivudine (Drug)
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Experimental
干预措施: Efavirenz (Drug)
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Experimental
干预措施: Lamivudine (Drug)
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Experimental
干预措施: Tenofovir (Drug)
结局指标
主要结局
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
时间窗: Week 24
Safety as measured by numbers of subjects with Serious Adverse Events (SAEs) and numbers of subjects with Adverse Events (AEs) leading to discontinuations
时间窗: Week 24
次要结局
- Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses(Weeks 48 and 96)
- Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation(Weeks 48 and 96)
- Changes from baseline in CD4+ T-cell counts(Weeks 24, 48, and 96)
- Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)(Weeks 24, 48, and 96)
- Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC(Week 24)
- Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC(Week 24)
- Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC(Week 24)
- Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC(Week 24)
- Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC(Week 24)
- Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC(Week 24)
研究者
研究点 (15)
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