NCT00323687已完成4 期
Switch to a Completely ONce Daily Regimen Containing Emtricitabine/Tenofovir - Fixed Dose Combination Plus Third QD Partner: "SONETT"
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48
研究概览
简要总结
There is an unmet medical need for potent ART regimens that make adherence to treatment even easier due to QD dosing, offer a good tolerability profile and fit into the daily life of patients.
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
- •Adult patients (over 18 years of age) of any ethnic group without restricted legal competence and who are capable of following the study instructions HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive PCR for HIV-1 RNA Stable (no interruption or change of regimen in last 3 months) AZT-and 3TC-containing regimen > 3 months No documented prior virologic failure (virological failure defined as 2 consecutive measurements 4 weeks apart with viral load of HIV-RNA > 400 copies/mL while on ART) CD4+ counts > 50 cells/µL Viral load < 50 copies/mL Karnofsky performance status ≥ 80% For women with childbearing potential, negative urine pregnancy test at Screening visit
排除标准
- •Serum phosphate level < 0.65 mmol/L Documented active opportunistic infections Subjects with previously documented K65R, 69S mutations or 3 or more thymidine analogue mutations Documented active malignant disease (excluding Kaposi sarcoma limited to the skin) Female of childbearing potential not willing to use a barrier method of contraception during heterosexual intercourse during the duration of study Women who are pregnant or breast feeding Known history of drug, medication or alcohol abuse within the last 12 months preceding the study Simultaneous participation in another study with an investigational drug or within less than one month prior to this study Inability or not willing to meet the requirements of the protocol History of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator Limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication Renal disease (creatinine clearance < 50 ml/min according to Cockroft_Gault formula) or severe hepatic, respiratory or cardiovascular disease Patients who have previously been enrolled into this study Contraindication for one of the study substances.
结局指标
主要结局
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48
时间窗: Week 48
次要结局
- Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 24(24 weeks)
- Time to failure or ART discontinuation. Virological failure is defined as 2 consecutive measurements 4 weeks apart with viral load of HIV-RNA > 400 copies/mL(Up to 48 weeks)
研究者
研究点 (2)
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