Use of Maraviroc (MVC) in Immunological Non-responder HIV-1-infected Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.
研究概览
简要总结
Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed.
Although the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution.
Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur.
Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.
With this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.
详细描述
Objectives:
- Evaluate the clinical efficacy of HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and with a complete and stable virologic suppression after 12 months of HAART. Patients could also being included if their CD4 slope has been stable without any improvement, with an absolute value around 200 cells/uL.
- Evaluate the effects of HAART intensification with MVC on the modification of immunologic and virologic parameters.
- Evaluate the tolerability of HAART intensification with MVC and the appearance of drug-related side effects.
Design:
This will be a randomised, multicenter, study that will evaluate HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and/or a stable CD4 slope without any improvement, with an absolute value around 200 cells/uL and with a complete and stable virologic suppression after 12 months of HAART.
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
- •age > or = 18
- •HIV-Abs positivity detected by ELISA and confirmed by Western-Blot
- •CD4 lymphocytes < 200/uL and/or CD4 recovery < 25% after at least 12 months of stable HAART
- •HIV-RNA < 50 cp/mL during the last 12 months
- •negative pregnancy test at least 14 days prior to treatment
- •understanding and signing the informed consent
排除标准
- •allergy/intolerance to the study drug
- •less than 1 year from any treatment with immunomodulatory agents
- •current OIs or neoplasms
- •current CVD or EKG abnormalities
- •current respiratory tract diseases or COPD
- •treatment with steroids within 4 weeks from treatment beginning
- •suspect of autoimmune disorder or chronic inflammatory disease
- •active IVDUs or alcohol addicts
- •AST and ALT > 2.5 ULD
- •serum creatinine > 1.5 ULD
- •ANC < 1000/uL
- •hemoglobin < 10 g/dL
- •platelets < 75.000/uL
- •reticulocytes > 2%
- •Karnofsky score < 50
研究组 & 干预措施
Maraviroc
Subjects in this group will add Maraviroc to their current HAART.
干预措施: Maraviroc (Drug)
结局指标
主要结局
CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.
时间窗: 3 and 12 months
次要结局
未报告次要终点
研究者
Stefano Rusconi
Researcher/Aggregate professor in infectious diseases
ASST Fatebenefratelli Sacco