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Published online October 18, 2004
PEDIATRICS Vol. 114 No. 5 November 2004, pp. e604-e611 (doi:10.1542/peds.2004-0274)
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ELECTRONIC ARTICLE

Two-Year Clinical and Immune Outcomes in Human Immunodeficiency Virus–Infected Children Who Reconstitute CD4 T Cells Without Control of Viral Replication After Combination Antiretroviral Therapy

Guity Ghaffari, PhD*, Dominick J. Passalacqua, MSc{ddagger}, Jennifer L. Caicedo, MD*, Maureen M. Goodenow, PhD*,{ddagger},§, John W. Sleasman, MD||

* Department of Pediatrics, Division of Immunology and Infectious Diseases
{ddagger} Department of Pathology, Immunology, and Laboratory Medicine, College of Medicine, University of Florida, Gainesville, Florida
§ University of Florida Shands Cancer Center, Gainesville, Florida
|| Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, College of Medicine, University of South Florida, and All Children's Hospital, St Petersburg, Florida

Objective.To evaluate 96-week clinical and immune outcomes to protease inhibitor–containing antiretroviral therapy.

Methods.A prospective study was conducted of 40 human immunodeficiency virus (HIV)-infected children who displayed viral suppression (VS) with successful immune reconstitution (IS), failure to suppress virus (VF) or develop immune reconstitution (IF), or discordant immune and viral responses (VF/IS) at 24 weeks posttherapy. All children enrolled had viral RNA >4.0 log10 copies per mL and were Centers for Disease Control ad Prevention immune stage 2 or 3. Clinical, viral, and immune outcomes were assessed during the subsequent 72 weeks.

Results.VS/IS and VF/IS groups displayed similar sustained increases in CD4 T cells, although viral levels rebounded by 48 and 96 weeks posttherapy to pretherapy levels in the discordant group. The VF/IS outcome group had significant increases in height and weight z scores compared with entry and were similar to the VS/IS group. After treatment, antigen-specific responses after tetanus immunization were similar in the VF/IS and VS/IS groups. Prevalence of HIV-associated illnesses decreased in both VS/IS and VF/IS but not in VF/IF response groups.

Conclusions.The findings indicate that viral replication under the selective pressure of protease inhibitors fails to exhibit the same deleterious impact on T-cell immunity as pretherapy viruses. CD4 T-cell counts may be a better predictor of disease progression and improvement in growth than viral burden in HIV-infected children who receive a protease inhibitor as part of a highly active antiretroviral therapy regimen.

Key Words: children • HIV • immune reconstitution • protease inhibitors • immunization • growth

Abbreviations: AIDS, acquired immune deficiency syndrome • HIV-1, human immune deficiency virus type 1 • VF/IS, viral failure/immune success • VS/IS, viral success/immune success • VF/IF, viral failure/immune failure • CDC, Centers for Disease Control and Prevention • NRTI, nucleoside reverse transcriptase inhibitor • RTV, ritonavir • NFV, nelfinavir • PBMC, peripheral blood mononuclear cell • PHA, phytohemagglutinin • {gamma}-IFN, {gamma}-interferon • ANOVA, analysis of variance

Accepted Jun 9, 2004.


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