Sequential HAART in Treatment Resistant HIV-1 Infected Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Changes in plasma HIV-1 RNA load
研究概览
简要总结
This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.
详细描述
Mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in HIV-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of HIV resistance mutations.
This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.
The objectives are to study the feasibility, safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available.
This is an open-label, crossover, pilot study. Patients that fail their current regimen, and who currently have no adequate treatment options left, will be randomized to start either an alternating triple combination, or to start a continuous quadruple regimen of drugs. After 6 weeks, patients will crossover from either strategy to the other strategy for another 6 weeks. Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks. In the study period when regimens are alternated, two combinations of three drugs with the least possible cross-resistance will alternate every week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •HIV-1 infected patients
- •At least 18 years of age
- •Males or non-pregnant, non-lactating females
- •Documented virological treatment failure on at least 3 classes of antiretroviral drugs
- •No adequate antiretroviral therapy possible with currently available antiretroviral agents
- •Virological treatment failure is defined as plasma HIV-1 RNA levels > 5000 while taking at least three different antiretroviral drugs
排除标准
- 未提供
研究组 & 干预措施
Continuous triple-class therapy
Patients will be treated with a regimen containing antiretroviral agents from 3 different classes
干预措施: Standard Continuous Highly Active Antiretroviral Therapy (HAART) (Drug)
Alternating therapy
Patients will be assigned to weekly alternating dual-class regimen
干预措施: Rapidly Cycled HAART (Drug)
结局指标
主要结局
Changes in plasma HIV-1 RNA load
时间窗: 12 weeks
次要结局
- Replicative fitness of the dominant quasispecies(12 weeks)
- Changes in the genotype of the dominant quasispecies(12 weeks)
- Changes in CD4+ and CD8+ cell counts(12 weeks)