The Effects of ProAlgaZyme Novel Algae Infusion Alone or in Combination With HAART on Markers of Immune Status, Dyslipidemia, Inflammation and Oxidative Stress in HIV or HIV/HBV Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- CD4+ T-lymphocytes
研究概览
简要总结
The purpose of this study is to determine the safety and effects in HIV patients of supplementation (4-20 fl. oz. daily) with ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, on markers of immune status, dyslipidemia, inflammation and oxidative stress alone or in combination with HAART (highly-active antiretroviral therapy).
详细描述
HIV infection and interventions such as HAART (highly-active antiretroviral therapy) are associated with dyslipidemia and increased markers of inflammatory and oxidative stress. These effects can hasten the progression towards AIDS and present serious cardiovascular complications. Therapeutic agents that can provide immune support with minimal side effects and/or reduce the adverse effects of HAART are in high demand worldwide. Such agents may help HIV patients to live a better quality of life, and may potentially improve the compliance with traditional therapies including HAART. This study is a single-center open-label design to evaluate the safety of ProAlgaZyme novel algae infusion and its effects in varying dosages on markers of immune status, dyslipidemia, inflammation and oxidative stress in patients with HIV or HIV/HBV co-infection, who may also be taking HAART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as HIV +ve or HIV/HBV +ve
- •Either/or:
- •had not taken antiretroviral drugs before (pre-HAART patients)
- •were treated with triple drug therapy for at least 3-6 months
排除标准
- •Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study.
- •Enrolled in another clinical study in the past 6 months.
结局指标
主要结局
CD4+ T-lymphocytes
时间窗: 12 weeks
HIV Viral Load
时间窗: 12 weeks
hsCRP (C-reactive protein)
时间窗: 12 weeks
Total cholesterol
时间窗: 12 weeks
Liver enzymes (ALT, ALP, GGT)
时间窗: 12 weeks
MDA (malonaldehyde) and thiol proteins
时间窗: 12 weeks
次要结局
- RBC and WBC counts(12 weeks)