Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events (IDEAL-Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 34
- 主要终点
- Death, all new/relapsing opportunistic infections and other grade 4 clinical endpoints within 24 weeks after randomization
研究概览
简要总结
The purpose of this study is to compare the early versus deferred initiation of antiretroviral combination therapy consisting of tenofovir, emtricitabine and atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).
详细描述
Objectives:
To compare the early versus deferred initiation of antiretroviral combination therapy consisting of tenofovir, emtricitabine and atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).
The primary objective of this study is as follows:
To compare the rates of clinical progression between both groups. Progression is defined as death, all new/relapsing opportunistic infections (OI), and other grade 4 clinical endpoints (evaluated by standardized toxicity tables) within 24 weeks after randomization.
The secondary objectives of this study are:
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
- •Adult (at least 18 years) HIV-1 infected subjects
- •Antiretroviral naïve HIV-1-infected patients who have developed an acute AIDS defining event, namely PCP or Toxoplasmosis (women receiving prior MTCT prophylaxis may be enrolled)
- •Patients who are able to take or to receive antiretroviral treatment and who are able to give written consent
排除标准
- •Renal failure or CrCl < 60 mL/min
- •Patients who are not able to initiate ART or with current contraindications against atazanavir/ritonavir
- •Other AIDS-defining events than PCP or TE (exceptions see below)
- •Pregnancy/Women of childbearing potential who want to become pregnant
结局指标
主要结局
Death, all new/relapsing opportunistic infections and other grade 4 clinical endpoints within 24 weeks after randomization
时间窗: 24 weeks
Clinical Progression (death, all new or relapsing OI, other Grade 4 clinical endpoint) within 24 weeks. For abnormalities not found in the Toxicity Tables, a Grade 4 event will be defined as potentially life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Patients who drop out of study observation before end of week 12 are counted as clinical progression.
次要结局
- incidence of immune reconstitution inflammatory syndrome(24 weeks)
- Hospitalization days after completion of initial OI treatment between both groups(24 weeks)
- efficacy and toxicity of the antiretroviral therapy(24 weeks)
- virological outcome(24 weeks)
- quality of life(24 weeks)
- immunological outcome(24 weeks)