Low rate of cmv end-organ disease in hiv-infected patients despite low cd4+ cell counts and cmv viremia: Results of ACTG protocol a5030

D. A. Wohl, M. A. Kendall, J. Andersen, C. Crumpacker, S. A. Spector, J. Feinberg, B. Alston-Smith, S. Owens, S. Chafey, M. Marco, S. Maxwell, N. Lurain, D. Jabs, C. Benson, P. Keiser, M. A. Jacobson

Research output: Contribution to journalArticle

Abstract

Purpose: To describe cytomegalovirus (CMV) end-organ disease (EOD) rate in AIDS patients with low CD4+ cell count despite HAART who were enrolled in a randomized, placebo-controlled trial of preemptive valganciclovir (VGCV) to prevent CMV EOD in those with CMV viremia. Methods: Subjects (N = 338) were HIV-infected with CD4+ count <100 cells/mm3, plasma HIV RNA >400 copies/mL, and on stable or no HAART. All underwent plasma CMV DNA PCR testing every 8 weeks (Step 1); those with detectable CMV DNA were randomized to VGCV or placebo (Step 2). Results: Plasma CMV DNA was detected in 68 (20%), of whom 4 developed CMV EOD. During Step 1, 53 died. Of the 47 who entered Step 2 (24 VGCV, 23 placebo), CMV EOD was diagnosed in 10 (4 VGCV, 6 placebo) and 15 died (7 VGCV, 8 placebo). Of those randomized to placebo, 14% were diagnosed with CMV EOD at 12 months. Conclusions: We observed a lower CMV EOD rate among subjects receiving HAART than predicted based on published literature. However, mortality was high in this study. Our findings suggest that preemptive anti-CMV therapy in patients with persistently low CD4+ cell counts in the current treatment era may not be warranted given the low incidence of CMV EOD and high all-cause mortality observed in this study population.

Original languageEnglish (US)
Pages (from-to)143-152
Number of pages10
JournalHIV Clinical Trials
Volume10
Issue number3
DOIs
StatePublished - Jan 1 2009
Externally publishedYes

Keywords

  • AIDS
  • CMV
  • Opportunistic disease prevention
  • Valganciclovir

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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    Wohl, D. A., Kendall, M. A., Andersen, J., Crumpacker, C., Spector, S. A., Feinberg, J., Alston-Smith, B., Owens, S., Chafey, S., Marco, M., Maxwell, S., Lurain, N., Jabs, D., Benson, C., Keiser, P., & Jacobson, M. A. (2009). Low rate of cmv end-organ disease in hiv-infected patients despite low cd4+ cell counts and cmv viremia: Results of ACTG protocol a5030. HIV Clinical Trials, 10(3), 143-152. https://doi.org/10.1310/hct1003-143