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Previous Volume 342:1085-1092 April 13, 2000 Number 15 Next

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ABSTRACT

Background Several agents are effective in preventing Mycobacterium avium complex disease in patients with advanced human immunodeficiency virus (HIV) infection. However, there is uncertainty about whether prophylaxis should be continued in patients whose CD4+ cell counts have increased substantially with antiviral therapy.

Methods We conducted a multicenter, double-blind, randomized trial of treatment with azithromycin (1200 mg weekly) as compared with placebo in HIV-infected patients whose CD4+ cell counts had increased from less than 50 to more than 100 per cubic millimeter in response to antiretroviral therapy. The primary end point was M. avium complex disease or bacterial pneumonia.

Results A total of 520 patients entered the study; the median CD4+ cell count at entry was 230 per cubic millimeter. In 48 percent of the patients, the HIV RNA value was below the level of quantification. The median prior nadir CD4+ cell count was 23 per cubic millimeter, and 65 percent of the patients had had an acquired immunodeficiency syndrome–defining illness. During follow-up over a median period of 12 months, there were no episodes of confirmed M. avium complex disease in either group (95 percent confidence interval for the rate of disease in each group, 0 to 1.5 episodes per 100 person-years). Three patients in the azithromycin group (1.2 percent) and five in the placebo group (1.9 percent) had bacterial pneumonia (relative risk in the azithromycin group, 0.60; 95 percent confidence interval, 0.14 to 2.50; P=0.48). Neither the rate of progression of HIV disease nor the mortality rate differed significantly between the two groups. Adverse effects led to discontinuation of the study drug in 19 patients assigned to receive azithromycin (7.4 percent) and in 3 assigned to receive placebo (1.1 percent; relative risk, 6.6; P=0.002).

Conclusions Azithromycin prophylaxis can safely be withheld in HIV-infected patients whose CD4+ cell counts have increased to more than 100 cells per cubic millimeter in response to antiretroviral therapy.

Source Information

From Harlem Hospital Center and Columbia University College of Physicians and Surgeons, New York (W.M.E.-S., S.B.M.); the Denver Public Health Department and the University of Colorado Health Sciences Center, Denver (W.J.B.); the Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis (L.B.G., J.P.M.); the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Md. (R.H., A.M.); Wayne State University, Detroit (L.C.); the Research and Education Group, Portland, Oreg. (D.Z.); Philadelphia FIGHT, Philadelphia (B.G.); and the Department of Veterans Affairs Medical Center, Washington, D.C. (F.G.).

Address reprint requests to Dr. El-Sadr at Harlem Hospital Center, Division of Infectious Diseases, 506 Lenox Ave., Rm. 3107, New York, NY 10037, or at wme1{at}columbia.edu.

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