A Prospective Randomized Trial of Structured Treatment Interruption(STI) Followed by Initiation of a New Antiretroviral Regimen(ARV) Versus Immediate Switching to a New ARV in HIV-Infected Patients Experiencing Virologic Failure on HAART
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 主要终点
- To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
研究概览
简要总结
The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response.
详细描述
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis
By withdrawing ARV drug pressure, resistant HIV virus will revert to wild-type. In treatment-experienced HIV patients who experience virologic failure, a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime.
Interventions:
Immediate Switch to Salvage Therapy: Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results.
Structured Treatment Interruption: Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results.
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.
- •On therapy with a triple ARV that includes a protease inhibitor and/or non-nucleoside reverse transcriptase inhibitor for the past 3 months with no changes in any agent of the combination in the past 14 days.
- •Virologic failure while on the combination as defined by a plasma HIV RNA > 1000 copies/mL measured on 2 occasions at least 4 weeks apart.
- •HIV RNA <500,000 copies/mL.
- •CD4 cell count must be > 50/mm3
- •Patients must not have a present history of opportunistic infections or acute illness requiring treatment within the preceding 30 days.
- •The patient has at least two new ARV available based on history, and at least two of these new agents will be included in the new salvage regimen.
排除标准
- •Active substance abuse which would interfere with the patient's ability to participate in this trial, or declared non-compliance.
- •Pregnancy or breast feeding.
- •Patients with any of the following abnormal laboratory test results at screening:· Hemoglobin<80 g/L, neutrophil count<750 cells/mL, Platelet<20,000 /mL· AST or ALT > 5X Upper Limit of Normal (ULN)· Creatinine > 250 umol/L
- •End stage organ disease
- •Patient with malignancy receiving systemic chemotherapy
- •Patient has need for immune modulators (interleukin, interferon, GMCSF etc) or prednisone. This excludes a short course of inhaled or oral steroids for asthma exacerbation)
结局指标
主要结局
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
次要结局
- 1. To prospectively determine differences in other virologic parameters through follow up between patients being switched to a salvage regimen with or without a STI.
- 2. To prospectively determine differences in change in CD4 count through follow up and at 24, 48 and 60 weeks following randomization between patients being switched to a salvage regimen with or without a STI.
- 3. To prospectively determine differences in the development or reactivation of opportunistic infections and survival between patients being switched to a salvage regimen with or without a STI at 60 weeks following randomization
- 4. To determine the proportion of virus of patients being treated with a STI that converts to wild-type and how that relates to the virologic response (% of patients with undetectable viral load sustained for 3 months).
- 5. To determine the impact of the STI on quality of life measures.
- 6. To determine the genotypic resistance pattern of virus from patients who fail treatment after suppression to <50 copies/mL on the salvage regimen and to compare results in those who do and do not receive an STI.