Lack of Effect on Survival of High-Dose Acyclovir and Zidovudine Compared with Zidovudine Alone for Acquired Immunodeficiency Syndrome

Abstract

To evaluate the effect of acyclovir on survival of adults with moderately advanced human immunodeficiency virus type 1 (HIV-1) infection, a randomized, double-blind, placebo-controlled study was conducted. A total of 334 adults with AIDS or a CD4 cell count less than 200 cells/mm³ were assigned to acyclovir 4 g per day or placebo, combined with zidovudine 500 mg per day. Characteristics of enrollees and duration of follow-up were similar in each treatment group. One-hundred and six patients died. No differences in survival were seen between treatment groups in any analyses, including intent-to-treat analyses and exploratory analyses censoring data after study therapy was discontinued, or in the subset of enrollees with CD4 cell counts less than 100 cells/mm³ or less than 50 cells/mm³. Types and time to first AIDS-defining diseases were similar in both groups. There were significantly fewer episodes of varicella-zoster virus (P<0.0001) and herpes simplex virus (P=0.0001) infection in patients assigned to acyclovir/zidovudine than to zidovudine alone. Both regimens had similar tolerability. These data do not support routine use of acyclovir as a treatment for HIV-1 infection.