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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