Low rate of CMV end-organ disease in HIV-infected patients despite low CD4+ cell counts and CMV viremia: results of ACTG protocol A5030.
OBJECTIVE
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.
Wohl
D A
DA
University of North Carolina, Chapel Hill, North Carolina, USA. wohl@med.unc.edu
Kendall
M A
MA
Andersen
J
J
Crumpacker
C
C
Spector
S A
SA
Feinberg
J
J
Alston-Smith
B
B
Owens
S
S
Chafey
S
S
Marco
M
M
Maxwell
S
S
Lurain
N
N
Jabs
D
D
Benson
C
C
Keiser
P
P
Jacobson
M A
MA
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy / Q000401:mortality* / Q000821:virology*; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000821:virology; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D000998:Antiviral Agents / Q000008:administration & dosage; D018791:CD4 Lymphocyte Count; D003587:Cytomegalovirus / Q000235:genetics / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000188:drug therapy / Q000401:mortality* / Q000821:virology; D004311:Double-Blind Method; D015774:Ganciclovir / Q000008:administration & dosage / Q000031:analogs & derivatives; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000401:mortality; D006801:Humans; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D016016:Proportional Hazards Models; D000077562:Valganciclovir; D014766:Viremia / Q000188:drug therapy / Q000453:epidemiology*
D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir