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Aim: Malnutrition increases the severity and mortality of HIV infection. Therefore, this field study was started and aimed to provide a major cohort of HIV-infected children with the colostrum- based food product ColoPlus (ColoPlus AB, Malmo, Sweden) and to investigate the effects of Co- loPlus on the nutritional status and immunological capacity of children including tolerability and safety of the product. Methods: In this major field program comprising 850 malnourished HIV positive children, 50 grams of ColoPlus was administrated for 4 weeks as the first meal in selected health facilities in Northern Uganda. Forty-eight of these children (8 months - 14 years of age) were recruited into a descriptive prospective study and were followed for 12 weeks. At the start (week 0) and at weeks 4, 8 and 12, CD4+ cell counts, serum albumin and hemoglobin were ana- lyzed. The remaining 802 patients were observed to register safety and tolerability of ColoPlus. Results: There was a general improvement of wellbeing of the children with increased body weight and decreased fatigue. In the descriptive study of the 48 children, there was a significant rise of the CD4+ values at week 4 (+15.4% ± 2.8%, p = 0.0001) compared to week 0, and at week 8 (+39.1% ± 3.9%, p < 0.0001), but a return towards the 0-values at week 12 (+2.1%, ±2.8%, NS). He- moglobin and serum albumin showed an almost similar trend. ColoPlus was well tolerated by all the 850 children and no side effects or adverse events were seen. Conclusion: These results show that addition of a colostrum-based food product to the daily diet is beneficial in HIV-positive malnou- rished children. An improvement in nutritional status as well as in immune capacity was seen. These effects were prolonged and remained at least 4 weeks after cessation of ColoPlus administration. * Corresponding author.

Management of HIV in Children Using a Bovine Colostrum-Based Food Product— An Observational Field Study