A CONTROLLED TRIAL OF ISONIAZID IN PERSONS WITH ANERGY AND HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION WHO ARE AT HIGH-RISK FOR TUBERCULOSIS

Background Patients with human immunodeficiency virus (HIV) infection and latent tuberculosis are at substantial risk for the development of active tuberculosis. As a public health measure, prophylactic treatme nt with isoniazid has been suggested for HIV-infected persons who have anergy and are in groups with a high prevalence of tuberculosis. Meth ods We conducted a multicenter, randomized, double-blind, placebo-cont rolled trial of six months of prophylactic isoniazid treatment in HIV- infected patients with anergy who have risk factors for tuberculosis i nfection. The primary end point was culture-confirmed tuberculosis. Re sults The study was conducted from November 1991 through June 1996. Ov er 90 percent of the patients had two or more risk factors for tubercu losis infection, and nearly 75 percent of patients were from greater N ew York City. After a mean follow-up of 33 months, tuberculosis was di agnosed in only 6 of 257 patients in the placebo group and 3 of 260 pa tients in the isoniazid group (risk ratio, 0.48; 95 percent confidence interval, 0.12 to 1.91; P=0.30). There were no significant difference s between the two groups with regard to death, the progression of HIV disease or death, or adverse events. Conclusions Even in HIV-infected patients with anergy and multiple risk factors for latent tuberculosis infection, the rate of development of active tuberculosis is low. Thi s finding does not support the use of isoniazid prophylaxis in high-ri sk patients with HIV infection and anergy unless they have been expose d to active tuberculosis. (C) 1997, Massachusetts Medical Society.