 | The 131st Annual Meeting (November 15-19, 2003) of APHA |
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| The 131st Annual Meeting (November 15-19, 2003) of APHA |
Maria Leticia S. Cruz, MD1, Christine Powell, MA2, Michael Hughes, PhD3, James M. Oleske, MD MPH4, Harland Winter, MD5, Ross E. McKinney, MD6, Carol Elgie, BS7, Lynette Purdue, PharmD8, David Wolf9, Shiara Ortiz-Pujols, BA10, Nancy R. Calles, RN, BSN11, James McNamara, MD12, Jack Moye, MD13, and for the Pediatric AIDS Clinical Trials Group (PACTG) protocol 247 team10. (1) Servico de D. Infecciosas (DIP HSE), Hospital dos Servidores do Estado, Rua Sacadura Cabral 178, Anexo IV, 5, Rio de Janeiro, 20221-903, Brazil, 55 21 2518 1941, mleticia@hse.saude.gov.br, (2) Statistical and Data Analysis Center, Harvard School of Public Health, 651 Huntington Avenue, FXB building, Room 606, Boston, MA 02115, (3) Statistical & Data Analysis Center, Harvard School of Public Health, 655 Huntington Avenue, Building 2, Room 407, Boston, MA 02115-6017, (4) Department of Pediatrics, University of Medicine and Dentistry of New Jersey, F-570A Medical Science Building, 185 S. Orange Ave., Newark, NJ 07103, (5) Pediatric GI Unit, Massachusetts General Hospital, 55 Fruit Street, VBK 107, Boston, MA 03224, (6) Pediatric AIDS Clinical Trials Unit, Duke University Medical Center, DUMC Post Office Box 3461, Durham, NC 27710-3461, (7) Frontier Science Technology & Research Foundation, 4033 Maple Road, Amherst, NY 14226-1056, (8) Pharmaceutical Affairs Branch, NIAID, National Institutes of Health, DHHS, 6700-B Rockledge Drive MSC 7620, Bethesda, MD 20892-7620, (9) Ross Products Division, Abbott Laboratories, 625 Cleveland Avenue, Columbus, OH 43215-1724, (10) Pediatric ACTG Operations Center, Social & Scientific Systems Inc., 8757 Georgia Avenue, 12th floor, Silver Spring, MD 20910, (11) Baylor International Pediatric AIDS Initiative, Texas Children's Hospital, 6621 Fannin Street, CC1570.00, Houston, TX 77030, (12) DAIDS, Pediatric Medicine Branch, NIAID, National Institutes of Health, DHHS, 6700-B Rockledge Drive MSC 7624, Room 5106, Bethesda, MD 20892-7624, (13) Center for Research for Mothers and Children, NICHD, National Institutes of Health, DHHS, 9000 Rockville Pike, Bldg. 6100, Rm. 4B11H, MSC 7510, Bethesda, MD 20892-7510
BACKGROUND/OBJECTIVE: HIV infection affects infant growth adversely. Breast-milk substitutes are recommended to prevent postnatal HIV transmission when safe and available. We evaluated the effect on growth of an increased caloric-density milk-based formula in infants born to HIV-infected women in the U.S. and Latin America. METHODS: PACTG247 randomized 2097 infants £17d old and ³1.8kg in a double-blind trial of 26-kcal/oz compared with standard 20-kcal/oz infant formula. HIV-DNA-PCR was performed at study week (SW)4, CD4+-count at SW8, and anthropometry at each visit. Tolerability was assessed by caregiver report. Preliminary analysis was performed on data through SW8 from uninfected infants only. Growth measures were compared by t-test and linear regression, qualitative treatment differences by Fisher's exact test, and CD4+-count distributions by Wilcoxon's test. RESULTS: Forty infants were HIV-infected. Of those remaining, 1027 received 26-kcal/oz formula and 1030 received standard formula. Treatment groups were comparable at baseline and in proportions lost to follow-up (11.4% vs. 10.5%) and completing treatment (77.6% vs. 78.3%). Weight growth (mean±SE) but not length or head circumference was greater with 26-kcal/oz (5.29±0.02 vs. 5.20±0.03kg at SW8, p=0.01). No significant difference in tolerability or median CD4+-count was found. Differences with 26-kcal/oz formula were greater among infants at international sites (280g in weight and 1.0cm in length at SW8, both p=0.01). CONCLUSION: Increased caloric-density formula feedings can increase growth over 8 or fewer weeks and are well tolerated in HIV-exposed newborns. Effects in HIV-infected infants specifically and beyond SW8 remain to be determined as this ongoing study completes follow-up and analysis. Similar interventions where feasible could provide a multifactorial effort to improve infant growth and prevent breast-milk HIV transmission.
Learning Objectives:
Keywords: HIV/AIDS, Maternal and Child Health
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: infant formula, increased caloric density
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.