A Phase II Clinical Trial to Assess Risk and Benefit of Oral Low Dose Prednisolone for HIV Infected People Prior to the Commencement of Antiretroviral Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Time to progression of HIV disease
研究概览
简要总结
There has been reports that low dose prednisolone stabilizes CD4-counts in HIV infected individuals. However, until now, there are no prospective randomized studies on the use of corticosteroids in latent HIV disease. Furthermore, low dose prednisolone (5 mg/d) is not sufficient tested for the risks and benefit for HIV patients especially for those living in poor settings with a higher risk of infections. This study will assess the benefit and the safety profile for low dose prednisolone therapy for patients in a region with limited resources and high prevalence of infections.
详细描述
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INTRODUCTION
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1 BACKGROUND
For treatment in advanced HIV infection, combination therapy with antiretroviral drugs (ARVs) is the best option under current international standards. The benefit of ARVs is best, if they are used relatively late in the course of the disease, commonly after a progression of years. However, under a global perspective, more than 90% of those who need ARVs world-wide have no access to them.
ARVs are not used in early stages of infection without significant immunodeficiency. Although a variable degree of immunodeficiency may be present even in early HIV disease, there is no established treatment for this phase.
Immunodeficiency is associated with a decline of a certain population of lymphocytes, the CD4 cells or T-helper cells. It seems to be a useful concept to postulate that a treatment which slows down this loss of CD4 cells could also slow down the progression of HIV disease.
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)
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 positivity. The HIV infection has to be confirmed according to WHO guidelines.
- •Patients must have signed a consent form prior to beginning protocol specific procedures.
- •Adult male and female patients, age ≥18 years. Female patients of childbearing potential must have a negative pregnancy test at study entry.
- •Patients must have a stage of HIV disease not yet requiring ARV therapy, defined by CDC stage A1, 2 or B1,
- •Patients must have a CD4 cell count ≥ 300 cells / µl.
- •No AIDS defining symptoms.
- •Patients must have a WHO performance status of 0,1,2
排除标准
- •Prior ARV therapy.
- •Active tuberculosis.
- •Abnormal laboratory results especially glucose level >160 mg/dl, liver enzymes AST and/or ALT ≥ 1,5 x ULN, bilirubin ≥ 4 x ULN, alkaline phosphatase ≥ 5 x ULN, creatinine ≥ 2 mg/dl (176,8 µmol)
- •Serious other diseases including psychiatric disorders
研究组 & 干预措施
prednisolone
5 mg prednisolone per os daily administration
干预措施: Prednisolone (Drug)
placebo
The placebo is designed to the equal look like the study medication.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Time to progression of HIV disease
时间窗: 2 years
The primary objective of the study is to assess the effect of the low dose prednisolone therapy on the time to progression of HIV disease. The time to progression is defined as the time between the baseline and the change of staging to advanced disease (CDC stage A3, B3 or C) or death
次要结局
- stabilisation of CD4 count(2 years)
- Overall survival(2 years)
- Quality of life(2 years)
- Rate of co-infections(2 years)
- Immune activation(2 years)
研究者
Dr. August Stich
MD, MSc
Medical Mission Institute, Germany