Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment. Randomized Study in Two Phases.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Lowering of plasma viral load after the first plasma infusion
研究概览
简要总结
To study the effect of passive immunotherapy (PIT) over the HIV-viral load and the CD4 T+-cell counts in patients who have failed to respond to three different Highly-Active Antiretroviral Therapy (HAART), and who have at the moment less than 100 CD4+-T cells/ml and a viral load over 20,000 copies/ml.
详细描述
Double blind comparative randomized study with placebo in two phases:
Phase I: I: A pilot study to asses the virologic efficacy in 30 patients will be done. They will be under the same HAART regimen, and they will be randomized to receive:
- Group I: HAART + PIT (n= 15)
- Group II: HAART + placebo (non-hyperimmune plasma) (n= 15)
Passive immunotherapy will consist in 500 cc of inactivated plasma with methylene-blue (standard inactivation method) from asymptomatic patients in early phases of the infection. A transfusion will be done, and a complete blood test including viral load and CD4+-T cell counts will be done at days 3, 7, 14, 21 and 28. The non-hyperimmune plasma (Group II) will be inactivated by the same method.
A second dose of hyperimmune plasma and placebo (Group I and Group II respectively) will be administered at +1 month from the beginning of the trial.
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
- Double
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 infected patients (CDC C category) confirmed by a Western-blot
- •CD4 T cell count under 100/ml form 6 months before the inclusion, and who have never been over 600 CD4 T cells/ml in the last 6 months, even if they have been receiving HAART.
- •The patients have received at least 3 different HAART regimens, and they have failed to respond (define failure: CD4 T cell count under 100/ml and plasma viral load over 20,000 copies/ml).
- •Plasma viral load over 20,000 copies/ml during at least 6 months.
- •Written informed consent
- •18 years old or older
排除标准
- •Asymptomatic patients who fill the A category of the CDC (1993)
- •Younger than 18 years old
- •Who are not expected to accomplish the treatment or the follow up visits
- •Pregnancy, breast-feeding women, or women who want to get pregnant
- •Denied consent
结局指标
主要结局
Lowering of plasma viral load after the first plasma infusion
Lowering of plasma viral load after a year
次要结局
- Elevation of CD4 T cell count
- Negativation of p24 HIV antigen
- HIV RNA mutations conferring resistance to HAART
- Development of C-events
- Dead
- Toxicity
- Accomplishment