NCT05580666招募中3 期
Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 51
- 主要终点
- All-cause mortality
研究概览
简要总结
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
详细描述
All participants in the REVIVE trial will be randomized (1:1) at the time of study entry to receive azithromycin prophylaxis or placebo for 28 days and will be followed for 24 weeks to determine the primary outcome measure. Total follow up duration will be 48 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded placebo-controlled
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
- •Documented HIV infection
- •CD4 count criteria:
- •i. CD4 count ≤ 100 cells/mm3 within past 4 weeks; or
- •ii. Documented CD4 nadir ≤ 100 cells/mm3 and complete interruption of ART for ≥ 6 months; or
- •iii. Documented CD4 count ≤ 100 cells/mm3 if ART-naive
- •Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment
排除标准
- •Contraindications to azithromycin:
- •i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or
- •ii. Personal or family history of QT-prolongation
- •Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)
- •Off-label azithromycin prophylaxis or requirement for prolonged (> 7 days) azithromycin (or macrolide) therapy
研究组 & 干预措施
Oral Azithromycin 250 mg once daily
Experimental
Active Azithromycin tablet
干预措施: Azithromycin Oral Tablet (Drug)
Oral matching placebo, once daily
Placebo Comparator
Matching placebo tablet
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 24 weeks after randomization
All-cause mortality over the first 24 weeks after randomization
次要结局
- All-cause mortality(12 weeks after randomization)
- Hospitalization(24 weeks after randomization)
- Composite of hospitalization or all-cause mortality(24 weeks after randomization)
研究者
研究点 (51)
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