A pediatric-friendly ARV dosage form: validation of palatability, flexibility, and accurate dosing of LPV/r

Organization Location: 
Seattle, Washington

Early antiretroviral (ARV) treatment is of utmost importance for saving the lives of infants and children living with HIV. Up to 52% of children left untreated die before they reach their second birthday. For this reason, WHO released their strong recommendation to start children younger than three years of age (and infants greater than 14 days of age) on ARV treatment. However, current treatment options for HIV-positive infants and children are insufficient, as little investment has been made in developing pediatric formulations that are safe, palatable, heat-stable and easy to administer. ARV treatment to infants and children is also complicated by the wide variance in age and body weight dosage requirements and the need for health care personnel trained in the administration of pediatric ARV drugs. The proposed project will test the feasibility of developing a heat-stable, dosing-flexible and palatable pediatric dosage form of lopinavir/ritonavir—the WHO-recommended first-line treatment for HIV in infants and children. The proposed dosage form will utilize a previously successful freeze-dried and fast-dissolving tablet approach, which meets the needs of pediatrics through accurate and flexible dosing. Using validation funds, the lead dosage form will undergo stability evaluation and palatability testing to optimize a formulation for infants and children.

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