IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
Status:
Completed
Trial end date:
2017-09-29
Target enrollment:
Participant gender:
Summary
Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In
severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate
antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to
weight ratio in severely malnourished children could also place them at higher risk of under
dosing compared to children with mild to moderate malnutrition. However, limited data are
available on the pharmacokinetics of ARVs in severely malnourished children. This study
addressed this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine
(3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children living with HIV,
compared to children with normal nutrition to mild malnutrition living with HIV.
Phase:
Phase 4
Details
Lead Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Mental Health (NIMH)