Impact of the Timing of Antiretroviral Therapy Initiation (Immediate Versus Early) on the Mortality Rate of HIV/AIDS Patients Hospitalized With an Opportunistic Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Mortality at 30 days.
研究概览
简要总结
The aim of this study is to compare the clinical response and mortality rate due to opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy (ART).
Immediate ART (iART) is defined as starting antiretroviral therapy within the first 48 hours after hospitalization. Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of the infectious disease specialist.
详细描述
This is an open-label, randomized clinical trial conducted at the Center for Research in Infectious Diseases (CIENI) of the National Institute of Respiratory Diseases "Ismael Cosío Villegas" (INER) in Mexico City. Adults (≥18 years) with confirmed HIV diagnosis and active opportunistic infections or AIDS-related malignancies are eligible. Participants must be ART-naïve or have discontinued ART for at least 3 months. Key exclusions include suspected cryptococcal meningitis, tuberculous meningitis, or cytomegalovirus retinitis.
Sample Size Calculation Sample size was calculated using a difference in proportions formula with 95% confidence level, 90% power, and 5% expected difference between groups. Based on 2022 hospitalization data (145 patients with HIV hospitalized) and a 6.9% mortality rate, assuming a 5% absolute reduction in mortality (from 6.9% to 1.9%) in the experimental group, the initial required sample size was 359 participants. This was adjusted for finite population (n=145), yielding 103 participants. Accounting for an anticipated 10% loss to follow-up, the final sample size was set at 114 participants (57 per group).
Study Procedures
Participants are stratified by CD4+ T-cell count (<50 vs. ≥50 cells/μL) and randomized 1:1 to either:
- Immediate ART (iART): Initiation of ART within 48 hours of hospital admission
- Conventional ART (cART): Initiation of ART once the opportunistic infection is controlled, at the discretion of the treating physician.
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 60 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection documented by ELISA or rapid test.
- •Age 18 years or older.
- •Hospitalized at the emergency department, intensive care unit, or clinical pulmonology ward of the National Institute of Respiratory Diseases (INER) with clinical criteria of an opportunistic infection or AIDS-related malignancy.
- •Candidate to initiate first ART regimen or presenting with first- or second-line ART failure.
- •ART-naïve or with ART discontinuation for at least 3 months prior to enrollment.
排除标准
- •Diagnosis or clinical symptoms suggestive of cryptococcal meningitis, tuberculous meningitis, or meningitis of any other cause.
- •Pregnant women.
- •Admitted exclusively for treatment of neurosyphilis without any other active opportunistic infection.
研究组 & 干预措施
Immediate Antiretroviral Therapy (iART).
Participants randomized to this arm will initiate antiretroviral therapy (ART) within 48 hours of hospital admission. The regimen will be selected by the treating physician based on clinical guidelines, with preference for second-generation integrase strand transfer inhibitor (INSTI)-based regimens (e.g., bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]), unless contraindicated.
干预措施: Antiretroviral Therapy (ART) (Drug)
Conventional Antiretroviral Therapy (cART).
Participants randomized to this arm will initiate ART once the opportunistic infection is considered controlled by the treating physician, at their discretion. The regimen will be selected by the treating physician based on clinical guidelines, with preference for second-generation INSTI-based regimens (e.g., BIC/FTC/TAF), unless contraindicated.
干预措施: Antiretroviral Therapy (ART) (Drug)
结局指标
主要结局
Mortality at 30 days.
时间窗: 30 days from ART initiation
Compare all cause mortality within 30 days of antiretroviral therapy (ART) initiation between immediate ART (iART) versus conventional ART (cART).
次要结局
- Mortality at 90, 180 and 365 days.(90, 180, 360 days from ART initiation.)
- Length of hospital stay.(From hospital admission to discharge (assessed up to 365 days).)
- Time to opportunistic infection resolution or recurrence.(Up to 365 days from ART initiation.)
- Incidence and classification of Immune Reconstitution Inflammatory Syndrome (IRIS).(Up to 365 days from ART initiation.)
- Incidence of adverse events Grade 2, 3, and 4.(Up to 365 days from ART initiation.)
- Kinetics of HIV viremia and CD4+ T-cell count.(Baseline, days 7, 14, 30, 90, 180 and 365.)
研究者
Gustavo Reyes-Teran
Principal Investigator
Centro de Investigación en. Enfermedades Infecciosas, Mexico