Study of the Influence of Immunological Repeated Stimuli With Commercial Vaccines Over the Viral Load (VL), Resistance Development and Specific Immunological Response Against HIV in Early Stage HIV Patients With Undetectable VL After HAART
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Times viral load increases over 20.000 copies/mL.
研究概览
简要总结
The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.
详细描述
As HIV-infected patients are considered immunocompromised, it is generally recommended that they have to receipt appropriate vaccines. However data are conflicting concerning potential harmful effects following the administration of commercial vaccines in HIV-infected patients. Transient increases ("blips") in the viral load have been described associated with a single dose of vaccine, with the potential risk of developing resistance to HAART. On the other hand, there has been described that patients with blips can have an increase in HIV-specific immune responses, which may help to improve the viral control.
Comparison: We have performed a clinical trial to evaluate the effect of a vaccination program in successfully treated HIV-infected adults on HAART compared to placebo.
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
- •Age >18 years
- •Asymptomatic HIV infection
- •CD4>500/mm3 >6 months prior to inclusion
- •CD4 nadir >300/mm3
- •Being under HAART > 1 year prior to inclusion
- •Viral load<200 copies/mL > 6 months prior to inclusion
- •Viral load previous to treatment >5000 copies/mL
- •Informed consent
排除标准
- •Pregnant women
- •Basal creatinine >2.5 mg/dL
- •Allergy to either a vaccine or a ingredient of it
- •Chronic hepatitis B
- •GOT/GPT > 250 IU/L
结局指标
主要结局
Times viral load increases over 20.000 copies/mL.
次要结局
- Development of resistance to antiretroviral therapy during the 18 months of the study
- Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
- Appearance of specific cytotoxic responses against HIV during the 18 months of the study
- Number of patients under 5000 copies/mL after 6 months of stopping HAART
- Development of symptoms C during the 18 months of the study
- Deaths during the 18 months of the study
- Toxicity during the 18 months of the study