Relation Between Darunavir Levels and Virological Efficacy, Integrated Proviral ADN and Resistance Mutations in HIV-infected Patients on Treatment With Darunavir/Ritonavir Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Virological efficacy
研究概览
简要总结
To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.
详细描述
To be enrolled, subjects had a plasma HIV-RNA <50 copies/mL for at least 6 months based, virologic failure while on a PI-containing regimen was allowed if the genotypic resistance tests showed no major resistance mutation associated to reduced susceptibility to DRV/rtv according to the International AIDS Society. Patients with transitory episodes of detectable plasma HIV-RNA viral load ("blip") preceded and followed by a plasma viral load <50 copies/mL without changes in antiretroviral treatment could also been included. The only exclusion criteria were pregnancy, hepatitis B coinfection and the concomitant use of drugs with potential major interactions with DRV/rtv pharmacokinetics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years, starting an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010
- •Plasma RNA-VIH < 50 copies/ml on stable antiretroviral treatment for ≥ 6 months
- •Absence of resistance mutations in the protease gene, based on treatment history and/or genotypic resistance testing. that would decrease darunavir susceptibility
排除标准
- •Pregnancy
- •Chronic B hepatitis
- •Genotypic resistance tests with evidence of resistance mutations in the protease gene that would decrease darunavir susceptibility
- •Concomitant use of drugs with potentially adverse interactions with darunavir-ritonavir pharmacokinetics, such as rifampin
研究组 & 干预措施
Darunavir-ritonavir monotherapy
HIV-infected patients with undetectable viral load for at least for 6 months on stable therapy and no darunavir related mutations in the HIV-protease gene
干预措施: Darunavir/ritonavir (Drug)
结局指标
主要结局
Virological efficacy
时间窗: 48 and 96 weeks
To correlate the plasma and intracellular (cell-associated)) DRV levels with the virological efficacy analyzed by the time to loss of virological response (TLOVR) algorithm, considering VF as either: 1) two consecutive viral load \>200 copies/mL, 2) a unique HIV-RNA \>200 copies/mL if followed by lost to follow-up, or 3) the reintroduction of nucleos(t)ides because any reason.
次要结局
- Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation(48 and 96 weeks)
研究者
Luis F. Lopez-Cortes
MD, PhD.
Hospitales Universitarios Virgen del Rocío