TULBPE023 - Poster Exhibition
Randomized clinical trial of immediate versus deferred antiretroviral therapy initiation in children older than one year with moderate immunodeficiency: the PREDICT Study (NCT00234091)
T. Puthanakit1,2, S. Vonthanak3, J. Ananworanich1,4,5, P. Kosaralaksa6, R. Hansudewechakul7, U. Vibol8, S.J. Kerr1, S. Kanjanavanit9, C. Ngampiyaskul10, J. Wongsawat11, W. Luesomboon12, N. Ngo-Giang-Huong13, K. Chettra3, T. Chuenyam1, T. Suwanlerk1, S. Ubolyam1, W.T. Shearer14, R. Paul15, P. Brouwers16, L. Mofenson17, L. Fox18, M.G. Law19, D.A. Cooper19, P. Phanuphak1, M. Chhi Vun3, K. Ruxrungtham1,4, on behalf of the PREDICT Study Group
1HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand, 2Faculty of Medicine, Chulalongkorn University, Department of Pediatrics, Bangkok, Thailand, 3National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia, 4Faculty of Medicine, Chulalongkorn University, Medicine, Bangkok, Thailand, 5SEARCH, Medicine, Bangkok, Thailand, 6Faculty of Medicine, Khon Kean University, Pediatrics, Khon Kaen, Thailand, 7Chiangrai Prachanukroh Hospital, Pediatrics, Chiang Rai, Thailand, 8National Pediatric Hospital, Pediatrics, Phnom Penh, Cambodia, 9Nakronping Hospital, Pediatrics, Chiang Mai, Thailand, 10Prapokklao Hospital, Pediatrics, Chantaburi, Thailand, 11Bamrasnaradura Infectious Disease Institute, Pediatrics, Nonthaburi, Thailand, 12Queen SavangVadhana Memorial Hospital, Pediatrics, Chonburi, Thailand, 13Institut de Recherchepour le Developpement IRD U174, Program for HIV Prevention and Treatment (PHPT), Chiang Mai, Thailand, 14Texas Children's Hospital, Baylor College of Medicine, Houston, United States, 15University of Missouri, Department of Psychology, St. Louis, United States, 16National Institute for Mental Health Center for Mental Health Research on AIDS, National Institutes of Health, Bethesda, United States, 17Pediatric, Adolescent and Maternal AIDS Branch Eunice Kennedy Shriver, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, United States, 18Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Thailand, 19The Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, Australia
Background: Current ART guidelines for perinatally-infected children >1year are based on adult trials due to lack of pediatric data. The PREDICT Trial investigated immediate versus deferred ART among Cambodian and Thai children.
Methods: Children age 1-12 years with CD4 15-24% were randomized to initiate ART at enrollment (immediate, n=150) or when CD4< 15% or CDC C events developed (deferred, n=150). Primary endpoints were AIDS-free survival and neurodevelopment Beery score at week 144.
Results: Mean(SD) age was 6.3(2.9) years; WAz, -1.32(1.03); HAz, -1.64(1.32); CD4 20(5)%; HIV RNA 4.6 (0.6) log10 copies/ml; characteristics were similar between arms. The retention rate was 96%. At week 144, 68(45%) of deferred children had started ART with a median (IQR) duration of 81(55 - 105) weeks. AIDS-free survival was 97.9% in immediate (3 CDC C events) and 98.7% in deferred arms (2 events); hazard ratio 1.5 (95%CI 0.3-9.2).
Conclusion: Immediate ART initiation in children >1 year with moderate immunodeficiency, CD4 15-24%, did not significantly increase AIDS-free survival or improve neurodevelopmental outcome by Beery compared to deferred ART initiation at CD4 < 15%. Nonetheless, %CD4 and height were higher.
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