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Previous Volume 337:315-320 July 31, 1997 Number 5 Next

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ABSTRACT

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 treatment with isoniazid has been suggested for HIV-infected persons who have anergy and are in groups with a high prevalence of tuberculosis.

Methods We conducted a multicenter, randomized, double-blind, placebo-controlled trial of six months of prophylactic isoniazid treatment in HIV-infected patients with anergy who have risk factors for tuberculosis infection. The primary end point was culture-confirmed tuberculosis.

Results The study was conducted from November 1991 through June 1996. Over 90 percent of the patients had two or more risk factors for tuberculosis infection, and nearly 75 percent of patients were from greater New York City. After a mean follow-up of 33 months, tuberculosis was diagnosed in only 6 of 257 patients in the placebo group and 3 of 260 patients in the isoniazid group (risk ratio, 0.48; 95 percent confidence interval, 0.12 to 1.91; P = 0.30). There were no significant differences 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. This finding does not support the use of isoniazid prophylaxis in high-risk patients with HIV infection and anergy unless they have been exposed to active tuberculosis.

Source Information

From the Medical Service, Veterans Affairs Medical Center, and Georgetown University, Washington, D.C. (F.M.G.); the Community Programs for Clinical Research on AIDS Statistical Center, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis (J.P.M., C.M.); the Addiction Research Treatment Corporation and Columbia University, New York (L.S.B.); the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Md. (R.H.); the Addiction Research Treatment Corporation, New York (S.L.J.); the Division of Infectious Diseases, Harlem Hospital Center, New York (M.K.); the Clinical Directors Network of Region II, Inc., New York (A.V.); the Tulane University Medical Center, New Orleans (C.L.B.); the New Jersey Community Research Initiative, Newark (G.P.); the Delaware Community Program for Clinical Research on AIDS, Wilmington (S.S.); and the Division of Infectious Diseases, Harlem Hospital Center, and Columbia University, New York (W.E.-S.).

Address reprint requests to Dr. Gordin at the Infectious Diseases Section (151B), VA Medical Center, 50 Irving St. NW, Washington, DC 20422.

Full Text of this Article

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Isoniazid Prophylaxis for High-Risk Patients with Anergy and HIV Infection
Aguado J. M., Pulido F., Moreno S., Dore G. J., Law M. G., Kaldor J. M., Gordin F., Matts J.
Extract | Full Text  
N Engl J Med 1997; 337:1696-1697, Dec 4, 1997. Correspondence

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