Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Median of CD4 counts change after 24 weeks
研究概览
简要总结
Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in treated and naïve patients, irrespective of the viral load.
The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3 during the last year, could lead to its immunological recovery.
60 patients will be included in this unicentric, prospective, randomized and stratified clinical trial. They will be randomized to either continue with its usual high activity antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as safety, clinical progression, immunological profile of the patients and the potential benefit of Maraviroc for HIV+ cirrhotic patients.
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
- •18 years of age or older
- •HIV infection
- •Patients receiving HAART treatment for at least one year with a sustained viral load equal or below 200 copies/ml
- •Viral load equal or below 200 copies/ml at the screening visit
- •Discordant patients: patients without an increment over 50 copies /ml of CD4 lymphocytes during the last year
- •Patients with an expected adherence to HIV treatment over 90% according to their physician.
- •Signed informed consent form
排除标准
- •Pregnancy or breast feeding or women planning pregnancy during the study duration
- •Any contraindication to treatment with Maraviroc
- •X4 tropism at inclusion
研究组 & 干预措施
Maraviroc
干预措施: Maraviroc (Drug)
结局指标
主要结局
Median of CD4 counts change after 24 weeks
时间窗: 24 weeks
次要结局
- Immunological profile(24 weeks)
- CD4 counts(24 weeks)
- Clinical progression(24 weeks)