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, Philip Keiser, M. A. Jacobson

Research output: Contribution to journalArticle

35 Citations (Scopus)

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

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Viremia
Cytomegalovirus
Cell Count
Placebos
Highly Active Antiretroviral Therapy
CD4 Lymphocyte Count
DNA
Mortality
Acquired Immunodeficiency Syndrome
Randomized Controlled Trials
valganciclovir
HIV

Keywords

  • AIDS
  • CMV
  • Opportunistic disease prevention
  • Valganciclovir

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Wohl, D. A., Kendall, M. A., Andersen, J., Crumpacker, C., Spector, S. A., Feinberg, J., ... 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

Low rate of cmv end-organ disease in hiv-infected patients despite low cd4+ cell counts and cmv viremia : Results of ACTG protocol a5030. / 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, Philip; Jacobson, M. A.

In: HIV Clinical Trials, Vol. 10, No. 3, 01.01.2009, p. 143-152.

Research output: Contribution to journalArticle

Wohl, DA, Kendall, MA, Andersen, J, Crumpacker, C, Spector, SA, Feinberg, J, Alston-Smith, B, Owens, S, Chafey, S, Marco, M, Maxwell, S, Lurain, N, Jabs, D, Benson, C, Keiser, P & Jacobson, MA 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, vol. 10, no. 3, pp. 143-152. https://doi.org/10.1310/hct1003-143
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, Philip ; Jacobson, M. A. / Low rate of cmv end-organ disease in hiv-infected patients despite low cd4+ cell counts and cmv viremia : Results of ACTG protocol a5030. In: HIV Clinical Trials. 2009 ; Vol. 10, No. 3. pp. 143-152.
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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.",
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AU - Andersen, J.

AU - Crumpacker, C.

AU - Spector, S. A.

AU - Feinberg, J.

AU - Alston-Smith, B.

AU - Owens, S.

AU - Chafey, S.

AU - Marco, M.

AU - Maxwell, S.

AU - Lurain, N.

AU - Jabs, D.

AU - Benson, C.

AU - Keiser, Philip

AU - Jacobson, M. A.

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N2 - 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.

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KW - Opportunistic disease prevention

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