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Previous Volume 334:1491-1497 June 6, 1996 Number 23 Next

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ABSTRACT

Background In the advanced stages of the acquired immunodeficiency syndrome (AIDS), cytomegalovirus (CMV) disease, particularly vision-damaging retinitis due to CMV, is common. We evaluated prophylactic treatment with orally administered ganciclovir as a way to prevent CMV disease.

Methods We conducted a prospective, randomized, double-blind, placebo-controlled study of CMV-infected persons with AIDS with either CD4+ lymphocyte counts of <50 per cubic millimeter or counts of <100 per cubic millimeter in those with a history of an AIDS-defining opportunistic infection. Patients were randomly assigned, in a 2:1 ratio, to receive either oral ganciclovir (1000 mg three times daily) or placebo.

Results The study was stopped after a median of 367 days of follow-up. In an intention-to-treat analysis, the 12-month cumulative rates of confirmed CMV disease were 26 percent in the placebo group (n = 239) and 14 percent in the ganciclovir group (n = 486), representing an overall reduction in risk of 49 percent in the ganciclovir group (P<0.001). The incidence of CMV retinitis after 12 months was 24 percent in the placebo group and 12 percent in the ganciclovir group (P<0.001). The prevalence of CMV-positive urine cultures at base line was 42 percent; after two months it was 43 percent in the placebo group and 10 percent in the ganciclovir group (P<0.001). The one-year mortality rate was 26 percent in the placebo group and 21 percent in the ganciclovir group (P = 0.14). Therapy with granulocyte colony-stimulating factor was more frequent in the ganciclovir group (24 percent) than in the placebo group (9 percent).

Conclusions In persons with advanced AIDS, prophylactic oral ganciclovir significantly reduces the risk of CMV disease.

Source Information

From the University of California, San Diego, La jolla (S.A.S., D.V.H.); St. Luke's–Roosevelt Hospital, New York (G.F.M.); the University of California, San Francisco, and Mount Zion Medical Center, San Francisco (J.P.L.); Methodist Hospital, Houston (T.S.); Oaklawn Physicians Group, Dallas (R.A.); R.K. Davies Medical Center, San Francisco (S.F.); Community Research Initiative of South Florida, Coral Gables (P.D.S.); Harbor–UCLA Medical Center, Torrance, Calif. (G.S.); and Roche Pharmaceuticals, Palo Alto, Calif. (W.B., R.W., M.J.S.).

Address reprint requests to Dr. Spector at the University of California, San Diego, Clinical Sciences Building, 9500 Gilman Dr., La Jolla, CA 92093-0672.

Full Text of this Article

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Oral Ganciclovir as Prophylaxis against Cytomegalovirus
Nicklin D., Wood C. A., Pulido F., Carnevali D., Rubio R., Spector S. A., Stempien M. J.
Extract | Full Text  
N Engl J Med 1996; 335:1395-1397, Oct 31, 1996. Correspondence

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