Low rate of CMV end-organ disease in HIV-infected patients despite low CD4+ cell counts and CMV viremia: results of ACTG protocol A5030.

TitleLow rate of CMV end-organ disease in HIV-infected patients despite low CD4+ cell counts and CMV viremia: results of ACTG protocol A5030.
Publication TypeJournal Article
Year of Publication2009
AuthorsWohl 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
Corporate AuthorsA5030 Study Team
JournalHIV Clin Trials
Volume10
Issue3
Pagination143-52
Date Published2009 May-Jun
ISSN1528-4336
KeywordsAcquired Immunodeficiency Syndrome, Adult, AIDS-Related Opportunistic Infections, Antiretroviral Therapy, Highly Active, Antiviral Agents, CD4 Lymphocyte Count, Cytomegalovirus, Cytomegalovirus Infections, Double-Blind Method, Ganciclovir, HIV Infections, Humans, Middle Aged, Polymerase Chain Reaction, Proportional Hazards Models, Viremia
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.

DOI10.1310/hct1003-143
Alternate JournalHIV Clin Trials
PubMed ID19632953
PubMed Central IDPMC2754189
Grant ListA19418 / / PHS HHS / United States
AI 69471 / AI / NIAID NIH HHS / United States
AI 69513-01 / AI / NIAID NIH HHS / United States
AI069434 / AI / NIAID NIH HHS / United States
AI069501 / AI / NIAID NIH HHS / United States
AI069502-01 / AI / NIAID NIH HHS / United States
AI069556 / AI / NIAID NIH HHS / United States
AI27659 / AI / NIAID NIH HHS / United States
AI27660 / AI / NIAID NIH HHS / United States
AI27661 / AI / NIAID NIH HHS / United States
AI27664 / AI / NIAID NIH HHS / United States
AI27673 / AI / NIAID NIH HHS / United States
AI32782 / AI / NIAID NIH HHS / United States
AI32783-13 / AI / NIAID NIH HHS / United States
AI34853 / AI / NIAID NIH HHS / United States
AI46370 / AI / NIAID NIH HHS / United States
AI46376 / AI / NIAID NIH HHS / United States
AI46381 / AI / NIAID NIH HHS / United States
AI50410 / AI / NIAID NIH HHS / United States
AI68634 / AI / NIAID NIH HHS / United States
AI68636 / AI / NIAID NIH HHS / United States
AI69411 / AI / NIAID NIH HHS / United States
AI69423-01 / AI / NIAID NIH HHS / United States
AI69432 / AI / NIAID NIH HHS / United States
AI69439 / AI / NIAID NIH HHS / United States
AI69450 / AI / NIAID NIH HHS / United States
AI69470-01 / AI / NIAID NIH HHS / United States
AI69474 / AI / NIAID NIH HHS / United States
AI69477 / AI / NIAID NIH HHS / United States
AI69494-01 / AI / NIAID NIH HHS / United States
AI69495 / AI / NIAID NIH HHS / United States
AI69532-01 / AI / NIAID NIH HHS / United States
M01 RR000046 / RR / NCRR NIH HHS / United States
M01 RR000046-460966 / RR / NCRR NIH HHS / United States
M01-RR00096 / RR / NCRR NIH HHS / United States
P30 AI050410 / AI / NIAID NIH HHS / United States
RR00046 / RR / NCRR NIH HHS / United States
RR00051 / RR / NCRR NIH HHS / United States
U01 AI069423 / AI / NIAID NIH HHS / United States