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临床试验/NCT01195077
NCT01195077已完成1 期

Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?

University of South Carolina2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2003年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
2
主要终点
Dietary algae influence on CD4 helper cells and HIV viral load

研究概览

简要总结

Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and animal studies of HIV inhibition by algae, we propose algal consumption as one unifying characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in Eastern Asia (<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults) strongly suggest that differences in IV drug use and sexual behavior are insufficient to explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of the daily diet for many people living in Chad, where prevalence of HIV has remained at less than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges between 1 to 2 tablespoons (3 - 13 grams).

HIV viral load is the main indicator of infection, however CD4 helper cell counts are most predictive of morbidity and mortality.We hypothesized that the consumption of algae could be important in diminishing the risk of HIV infection, and subsequent progression, possibly by enhancing the immune response.

详细描述

Twelve HIV+ patients not on antiretroviral therapy were clinically evaluated and enrolled in the three-week study. Subjects received 10 algae capsules/d. Laboratory tests of CD4 counts and HIV RNA were performed at baseline, week 1, week 2, and week 3, and then once a month. Six subjects continued for between 4 and 14 months. In addition to CD4 lymphocyte counts and viral loads, subjects were evaluated monthly for Complete Blood Counts (CBC), Liver profile, Basic Metabolic Panel, and some subjects were evaluated for thyroid function and cholesterol. All subjects completed standard HIV Quality of Life questionnaires at each clinic visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of HIV
  • Able to swallow pills

排除标准

  • Allergy to iodine/seafood
  • Thyroid disease
  • Not taking antiretroviral therapy

结局指标

主要结局

Dietary algae influence on CD4 helper cells and HIV viral load

时间窗: Once a week for first 3 weeks, then once a month

The first 6 subjects participated for 3 weeks. After analysis of the results, it was determined that there were no side effects and some indication of benefit. The next 6 subjects participated for up to 14 months.

次要结局

  • Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit?(Participants were randomized to one of 3 treatments.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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