Double blind, placebo controlled trial of high dose acyclovir for the prevention of cytomegalovirus (CMV) disease in late stage HIV disease. European-Australian Acyclovir Study Group.

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

Double blind, placebo controlled trial of high dose acyclovir for the prevention of cytomegalovirus (CMV) disease in late stage HIV disease. European-Australian Acyclovir Study Group.

Int Conf AIDS. 1992 Jul 19-24;8(1):Mo15 (abstract no. MoB 0056). Unique Identifier : AIDSLINE ICA8/92400011
Youle M

Abstract: OBJECTIVES: To evaluate the efficacy and safety of high dose acyclovir as prophylaxis against CMV disease in HIV seropositives with low CD4 positive cell (CD4) counts and to ascertain any survival benefit. METHODS: Three hundred and two CMV seropositive subjects with two consecutive CD4 counts less than 150/cu mm and no AIDS defining herpes simplex (HSV) or CMV disease were randomised to received acyclovir 800 mg 6 hourly or matching placebo for 48 weeks. The study was conducted at 19 centres in Europe and Australia. End points were confirmed diagnosis of CMV disease, death or 3 episodes of HSV, varicella zoster virus (VZV) or Epstein-Barr virus (EBV) disease. Subjects were reviewed monthly. Sequential analyses of time to CMV disease and time to death were performed. RESULTS: Data on the first 234 subjects showed no difference in age, sex or race or in baseline CD4 count or antiretroviral therapy between the treated and untreated group. The study was stopped when the sequential analysis showed that the risk of developing CMV disease was not reduced by acyclovir. CMV disease occurred in 16/134 treated versus 9/129 untreated subjects included in the sequential analysis. At the time of stopping the study there had been 18 deaths (6 on acyclovir, 12 on placebo) on, or within 4 weeks of stopping, study drug. Probability of dying by 48 weeks was reduced on acyclovir by approximately 50% (p less than 0.05). Detailed analysis of all data from 302 subjects will be presented. CONCLUSIONS: This study, whilst failing to show any benefit of high dose acyclovir as prophylaxis against CMV disease, had revealed a survival benefit to this treatment. This is in agreement with Wellcome study H56-002 which showed a decreased probability of dying in AIDS and ARC patients receiving acyclovir.

Keywords: Acquired Immunodeficiency Syndrome/COMPLICATIONS/*DRUG THERAPY/ MORTALITY Acyclovir/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Antibodies, Viral/BLOOD Australia Cytomegalovirus/IMMUNOLOGY Cytomegalovirus Infections/COMPLICATIONS/*PREVENTION & CONTROL Double-Blind Method Europe Herpesviridae Infections/COMPLICATIONS/PREVENTION & CONTROL Human Risk Survival Rate ABSTRACT
921230
M92C5336

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