Clinical Pilot, Open, Comparative and Randomized Trial to Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients with HIV-1 viral load < 50 copies /mL
研究概览
简要总结
Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
详细描述
The probability of achieving viral replication suppression during the treatment with DRV has been related to both the extent of viral resistance to DRV (inhibitory concentration 50%, IC50) and the drug concentration. Moreover, the DRV virtual inhibitory quotient (vIQ) has been related significantly with the virological response to DRV treatment. So patients with a DRV vIQ >= 1,5 had a 8-times higher probability of having viral load < 50 copies/mL after 24 weeks of treatment than those having a vIQ < 1,5.
Considering the previous arguments, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a DRV vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
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
- 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
- •Age >= 18 years.
- •HIV-infected patients.
- •Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
- •HIV viral load < 50 copies/mL for at least 12 weeks.
- •Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
- •Darunavir vIQ >=
- •Subject able to follow the treatment period.
- •In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
- •Signature of the informed consent.
排除标准
- •AIDS-defining illness in the last 4 weeks.
- •Suspicion of unsuitable antiretroviral treatment compliance.
- •In women, pregnancy or breastfeeding.
- •Record or suspicion of incapability to cooperate as appropriate.
研究组 & 干预措施
1
Darunavir 900mg + ritonavir 100 mg once a day
干预措施: Darunavir 900mg + ritonavir 100 mg once a day (Drug)
2
Darunavir 600mg + ritonavir 100mg twice day
干预措施: Darunavir 600mg + ritonavir 100mg twice day (Drug)
结局指标
主要结局
Proportion of patients with HIV-1 viral load < 50 copies /mL
时间窗: Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48
次要结局
- Karnofsky index(Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48)
- DRV plasma trough concentration(Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48)
- Adverse events(Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48)
- Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides)(Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48)
- Treatment adherence (assessed by the physician, but not recovered in the data base)(Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48)
- DRV Virtual inhibitory quotient (vIQ)(Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48)
- CD4 and CD8 lymphocytes count(Screening, Basal, week 12, week 24, week 36 and week 48)
- Physical examination including weight and height(Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48)
- Genotype, if virological failure occurs(When virological failure)