Making an Early Diagnosis of Talaromycosis - a Strategy to Reduce Morbidity and Mortality in Advanced HIV Disease in Southeast Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,411
- 试验地点
- 2
- 主要终点
- Incidence of microscopy and/or culture-confirmed talaromycosis
研究概览
简要总结
This is a research study to determine whether a new antigen detection test called Mp1p EIA can make an early diagnosis of talaromycosis from the blood and urine of patients. Talaromycosis is a life-threatening infection caused by a fungus endemic in Southeast Asia commonly found in patients with advanced HIV disease called Talaromyces marneffei.
详细描述
This study aims to determine the diagnostic and prognostic values and the clinical impact of Talaromyces marneffei antigenemia (TmAg) in patients with advanced HIV disease using a novel enzyme immunoassay (EIA) detecting Tm-specific cell wall mannoprotein Mp1p. The data generated will be used to inform the design of future diagnostic clinical trials to test the utility of screening and providing pre-emptive antifungal therapy to prevent disease and reduce HIV mortality in Southeast Asia.
The primary objective is to screen for TmAg and determine its diagnostic and prognostic performance in symptomatic and asymptomatic HIV-infected patients with a CD4 count ≤100 cells/mm3.
We will test the following hypotheses:
- In symptomatic hospitalized patient Cohort 1, the sensitivity of the Mp1p EIA will be higher than conventional culture method while simultaneously specificity is higher than 95% for diagnosing culture-confirmed talaromycosis over a six-month follow up period
- In asymptomatic outpatient Cohort 2, there will be at least 30% difference in risk of talaromycosis development in TmAg-positive patients compared to TmAg-negative patients over a twelve-month follow up period
- TmAg concentration predicts development of talaromycosis
Secondary Objectives include:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection (at least 2 of 3 HIV antibody tests are positive), AND
- •HIV-infected age ≥18 years, AND
- •CD4 count ≤100 cells/mm3 within the past 3 months, AND
- •Antiretroviral therapy (ART) naïve OR recent ART ≤3 months OR suspected or confirmed treatment failure on ART ≥12 months (defined as poor treatment adherence, treatment interruption, or having a confirmed HIV RNA ≥1,000 copies)
- •Cohort 1: suspected to have an active infection
- •Cohort 2: not suspected to have or being evaluated for an active infection
排除标准
- •Unlikely to attend regular clinic visits
- •History of recent talaromycosis or histoplasmosis infection currently on antifungal therapy
结局指标
主要结局
Incidence of microscopy and/or culture-confirmed talaromycosis
时间窗: over six to twelve months
Cumulative incidence of microscopic and or culture-confirmed talaromycosis over six to twelve months will be recorded
次要结局
- Incidence of stage III and IV AIDS events(over six to twelve months)
- Incidence of loss to follow up(over six to twelve months)
- Mortality in the subsequent six months (Cohort 1) and twelve months (Cohort 2)(over six to twelve months)
- Hospitalizations in the subsequent six to twelve months(over six to twelve months)
- Incidence of other major HIV-associated opportunistic infections(over six to twelve months)