HAART in Rwandan children 0-15 years: incidence, severity, risk factors and long-term outcome of adverse effects
12 / 2005 - 08 / 2010
Nederlandse Organisatie voor Wetenschappelijk Onderzoek - NWO
* Scientific rationale: Highly Active Antiretroviral Therapy (HAART) has markedly improved the prognosis of HIV infected infants and children in developed countries. In resource limited settings, however, the prognosis of HIV infected infants and children is extremely poor with 50% dying before the age of 2 years. Therefore, the expansion of treatment programmes to the pediatric population is urgently needed. As a result, morbidity from short-term and long-term complications of antiretroviral therapy will grow in importance. The safety and tolerability of HAART regimens will be crucial factors in determining adherence and thereby efficacy of therapy and the risk of treatment failure. As in adults, adverse effects appear to be a common reason for changing antiretroviral medication in children. However, systematic information on the incidence, severity, risk factors and long-term outcome of treatment-limiting complications such as anaemia, neutropenia, rash, peripheral neuropathy and lipodystrophy of HAART in infants and children is sparse and lacking for the African pediatric setting. It is also unknown if the high background rates of tuberculosis and other opportunistic infections, malaria, malnutrition, and diarrhoeal diseases in children add to the risk of toxicity of antiretrovirals and influence HAART efficacy. Insight into these factors is essential for optimization of treatment and determination of effective interventions. In the light of the expansion of treatment programmes in children, observational studies will be important to asses the clinical effectiveness and limitations of these treatment programmes. * Capacity developmental part: The number of treated children in Rwanda will increase rapidly. The local demand is to strengthen the current capacity on pediatric research within the Treatment and Research for AIDS Center (TRAC) and Centre Hospitalier Universitaire de Kigali (CHUK). The roll-out of HAART programmes to children in Kigali offers an excellent opportunity to form a pediatric cohort for observational studies on the efficacy and complications of HAART. The design of the study is to prospectively collect data on the incidence, severity, risk factors and long-term outcome of adverse events associated with HAART in children between 0-15 years of age. Capacity building in this project will focus on training of medical and nursing staff to conduct observational clinical research. One Rwandan medical doctor will be trained to PhD level. Moreover, in the project a sustainable pediatric database management system will be established.