NCT01638650已完成1 期
To Determine the Effect of the Modified SQV/r (Saquinavir-boosted by Ritonavir) Regimen (500/100 mg for the 1st Week Followed by 1000/100 mg for the 2nd Week) on the QTc Interval, Pharmacokinetics, and Antiviral Activity in Treatment-naive HIV-1 Infected Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Maximal increase in QTc interval (continuous Holter 12-lead ECG monitoring time points Days 1, 3, 4, 7, 10 and 14)
研究概览
简要总结
This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients. Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second week. The study treatment will be given in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines. Anticipated time on study treatment is 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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, >/= 18 years of age
- •HIV-1 infection
- •Currently treatment-naïve and eligible to initiate a ritonavir-boosted Protease Inhibitor based regimen and willing and able to initiate saquinavir/ritonavir therapy for the first 14 days; the saquinavir/ritonavir regimen will be in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines
- •Body mass index 18-32 kg/m2, inclusive
- •Female patients of childbearing potential and male patients with female partners of childbearing potential must use 2 methods of contraception as defined by protocol during the study and for at least one month after the last dose of study drug
- •Non-smoker or patients who have stopped smoking more than three months prior to Day 1 of the study
排除标准
- •Coinfection with hepatitis B or C (acute or chronic)
- •Anticipated use or need for significant concomitant medical treatment during the study period, other than background antiretroviral therapy
- •Participation in a clinical study with an investigational drug or device within 3 months prior to Day 1 of the study
- •Pregnant or lactating women
- •Any clinically relevant history of substance abuse or addiction including alcohol and/or other drugs of abuse
- •Special dietary restrictions that would prohibit consumption of standardized meal (e.g. vegetarian, vegan, gluten-free, lactose-free, kosher)
- •Decompensated liver disease
- •Congenital or documented acquired QT prolongation
- •Electrolyte disturbances, particularly uncorrected hypokalaemia
- •Clinically relevant bradycardia
- •Clinically relevant heart failure with reduced left-ventricular ejection fraction
- •Previous history of symptomatic arrhythmias
- •History of clinically significant gastro-intestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, , hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis
研究组 & 干预措施
Single Arm
Experimental
干预措施: Nucleoside Reverse Transcriptase Inhibitor (NRTIs) (Drug)
Single Arm
Experimental
干预措施: ritonavir (Drug)
Single Arm
Experimental
干预措施: saquinavir [Invirase] (Drug)
结局指标
主要结局
Maximal increase in QTc interval (continuous Holter 12-lead ECG monitoring time points Days 1, 3, 4, 7, 10 and 14)
时间窗: 14 days
次要结局
- Pharmacokinetics: Plasma concentrations(Pre-dose and 2, 4, 6, 8 and 12 hours post-dose, Days 3, 4, 7, 10 and 14)
- Pharmacodynamics: Change in HIV-RNA levels(from baseline to Day 14)
- Safety: Incidence of adverse events(approximately 6 months)
- Change in ECG parameters(from baseline to Day 14)
- Correlation between saquinavir plasma concentration and QTc interval changes(approximately 6 months)
研究者
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