Prospective study of Lopinavir based ART for HIV infected children globally; phase IIIb clinical trial in Ifakara.
The WHO antiretroviral treatment guidelines reemphasize the need to treat all HIV-infected children below 5 years of age and for children less than 3 years of age to initiate therapy with a ritonavir-boosted lopinavir (LPV/r) based regimen. However, by making this recommendation “when feasible,” WHO recognizes the programmatic complexity of providing infants and young children with the currently available LPV/r liquid (80/20mg) or baby tablets (100/25mg) formulations. A new formulation of LPV/r has been developed by Cipla pharmaceuticals, India, consisting of LPV/r pellets (40/10mg). This new formulation does not need refrigeration, is alcohol-free and can be opened and administered orally to infants and young children. A pharmacokinetics study of this new formulation showed that the exposure to LPV/r from pellets is comparable with syrup and its acceptability is better. This study (also dubbed the LIVING study) aims to provide supportive clinical data on feasibility, efficacy, safety, and pharmacokinetics of LPV/r-based therapies for children in routine treatment settings, and will be based on the existing LPV/r pellets, which already represent a clear advantage in comparison with the liquid formulation.
The specific aims of the study are: 1) Evaluate the effectiveness of LPV/r pellets in addition to AZT/3TC (or ABC/3TC) paediatric fixed dose combination tablet under routine treatment conditions in HIV-infected infants and children, 2) Document the safety of LPV/r pellets and AZT/3TC or ABC/3TC, 3) Assess the population pharmacokinetics of LPV/r and NRTIs when administered as LPV/r pellets plus AZT/3TC or ABC/3TC, 4) Measure adherence to the new formulation, and 5) Evaluate children acceptability of the LPV/r pellets and associated dual NRTIs as well as ease of use by the care giver.