Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group

N Engl J Med. 1996 Jun 6;334(23):1491-7. doi: 10.1056/NEJM199606063342302.


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 < or = 50 per cubic millimeter or counts of < or = 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 367 days of follow-up. In an intention-to-treat analysis, the twelve 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 < 0.0001). 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 < 0.0001). 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, phophylactic oral ganciclovir significantly reduces the risk of CMV disease.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS-Related Opportunistic Infections / prevention & control*
  • Acquired Immunodeficiency Syndrome / complications
  • Acquired Immunodeficiency Syndrome / mortality
  • Administration, Oral
  • Adult
  • CD4 Lymphocyte Count
  • Cytomegalovirus Infections / etiology
  • Cytomegalovirus Infections / prevention & control*
  • Double-Blind Method
  • Female
  • Ganciclovir / administration & dosage*
  • Humans
  • Male
  • Prospective Studies
  • Survival Analysis
  • Treatment Outcome


  • Ganciclovir