NCT00337467已完成3 期
Phase IIIb Multicenter, Single Arm, Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Maintenance With Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in HIV-Infected Patients Evidencing Virologic Suppression OREY (Only REYataz) Study
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Treatment Failure Through Week 48
研究概览
简要总结
The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks).
- •Absence of evidence or suspected virologic failure on antiretroviral therapy
- •Absence of known primary mutations in the protease gene
- •Only 1 highly active antiretroviral therapy (HAART) prior to current one
- •HIV RNA < 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed)
- •On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI + tenofovir [TDF]) for at least 8 weeks before study entry, without treatment-limiting adverse effects
排除标准
- •Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
- •Active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease)
- •Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil Fumarate (TDF) or emtricitabine (FTC).
- •CD4 < 100 cells/mm3
- •Grade IV laboratory values: Hemoglobin < 6.5 g/dL or white blood cells (WBC) <800/mmm3 or absolute neutrophil count < 500/mm3, or platelets < 20,000/mm3 or diffuse petechiae.
研究组 & 干预措施
A1
Experimental
干预措施: Atazanavir + Ritonavir (Drug)
结局指标
主要结局
Percentage of Participants With Treatment Failure Through Week 48
时间窗: Week 48
Treatment Failure through Week 48 defined as virologic rebound (HIV RNA \>=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) \>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \>=400 c/mL followed by discontinuation of study therapy.
次要结局
- Cumulative Proportion of Participants Without Treatment Failure Through Week 100(Through Week 100)
- Proportion of Participants With Virologic Rebound Through Week 96(Through Week 96)
- Percentage of Participants With Virological Rebound Through Week 96(Week 96)
- Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48(Baseline, Week 48)
- Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96(Week 96)
- Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48(Week 48)
- Percentage of Participants With Treatment Failure Through Week 96(Week 96)
- Mean Change From Baseline in CD4 Cell Count at Week 48(Baseline, Week 48)
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs(From Baseline through Week 96)
- Percentage of Participants With Virological Rebound Through Week 48(Week 48)
- Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24(Baseline, Week 24)
- Mean Change From Baseline in CD4 Cell Count at Week 96(Baseline, Week 96)
- Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96(Baseline, Week 96)
研究者
研究点 (1)
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