ADJUNCT VITAMIN A THERAPY FOR TUBERCULOSIS AND HIV/AIDS
ADJUNCT VITAMIN A THERAPY FOR TUBERCULOSIS AND HIV/AIDS
批准号:
2651773
负责人:
RICHARD D SEMBA
金额:
$49.97万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-09-15 至 2003-08-31
关键词:
AIDS AIDS therapy African Mycobacterium tuberculosis adult human (21+) antitubercular agents clinical research clinical trials combination chemotherapy dietary supplements human immunodeficiency virus human subject human therapy evaluation microorganism disease chemotherapy nutrition related tag retinoids tuberculosis vitamin therapy
中文摘要
描述(改编自摘要):到2000年,一些估计
13.8%的艾滋病毒感染者将同时感染
结核病(TB)。 尽管结核病化疗有效,
仍然非常高,没有简单,廉价的干预措施,
已知可以提高艾滋病毒和结核病患者的存活率。 之前
抗生素治疗的发现,鱼肝油形式的维生素A,
维生素A的有效来源,是结核病的标准治疗方法,
个一百年 维生素A对正常的免疫功能至关重要,
维生素A补充剂已被许多国家采用,
儿童死亡率。 在艾滋病毒感染期间,维生素A缺乏症一直是
与美国、海地、马拉维和
乌干达 研究人员的初步研究表明,90%以上的成年人,
艾滋病毒和结核病是维生素A缺乏症。 维生素A是否
补充是否会降低这些患者的死亡率尚不清楚。 的
这项研究的目的是确定每日维生素A
与结核病化疗同时给予补充剂,
感染艾滋病毒和结核病的成年人的死亡率。 研究者建议进行一项
随机、双盲、安慰剂对照临床试验
在Zomba为1100名感染艾滋病毒的肺结核成年人提供维生素A治疗,
马拉维是一个艾滋病毒和结核病流行率很高的国家。 死亡
在这些患有艾滋病毒和结核病的成年人中,
结核病化疗。 成人将接受标准的结核病化疗(异烟肼,
利福平、链霉素、吡嗪酰胺),随后
异烟肼和乙胺丁醇治疗6个月)和辅助治疗
维生素A或安慰剂治疗同时。 参与者将被
入组后随访24个月的生命事件。 如果附加
维生素A疗法被证明可以降低患有艾滋病毒和结核病的成年人的死亡率,
这种干预将具有已知的最高成本效益比之一,
因为辅助维生素A治疗的费用是每人80美分,
可以很容易地与结核病化疗结合。
英文摘要
DESCRIPTION (adapted from the Abstract): By the year 2000 some estimate
that 13.8 % of all individuals with HIV will be co-infected with
tuberculosis (TB). Despite effective TB chemotherapy, mortality rates
remain extremely high, and no simple, inexpensive intervention is available,
known to increase survival in adults with HIV and TB. Prior to the
discovery of antibiotic treatment, Vitamin A in the form of cod-liver oil, a
potent source of Vitamin A, was the standard treatment for TB for over one
hundred years. Vitamin A is essential for normal immune function, and
Vitamin A supplementation has been adopted by many countries to reduce
mortality in children. During HIV infection, Vitamin A deficiency has been
associated with increased mortality in the United States, Haiti, Malawi, and
Uganda. The researchers preliminary studies show that >90 % of adults with
HIV and TB are Vitamin A-deficient. However, whether Vitamin A
supplementation will reduce mortality in these patients is not known. The
objective of the study is to determine whether daily Vitamin A
supplementation, given concurrently with TB chemotherapy, will reduce
mortality in adults with HIV and TB. The Investigator proposes to conduct a
randomized, double-masked, placebo-controlled clinical trial of daily
Vitamin A therapy for 1100 HIV-infected adults with pulmonary TB in Zomba,
Malawi, a population with a high prevalence of HIV and TB. The mortality
rate is 45 % by 24 months in these adults with HIV and TB who have undergone
TB chemotherapy. Adults will receive standard TB chemotherapy (isoniazid,
rifampicin, streptomycin, pyrazinamide) for the first two months, followed
by isoniazid and ethambutol for the following six months) and adjunct
Vitamin A or placebo therapy at the same time. Participants will be
followed for vital events for 24 months after enrollment. If adjunct
Vitamin A therapy is shown to reduce mortality in adults with HIV and TB,
this intervention would have one of the highest cost benefit ratios known,
because adjunct Vitamin A therapy would cost about 80 cents per person and
could be readily incorporated with TB chemotherapy.
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