Long-term safety was assessed at 24 weeks primary and at 48 weeks in all treated subjects. Participants, sponsor personnel, investigators, and study site personnel involved in the treatment or evaluation of the participants were unaware of the treatment group assignments. Efficacy responses were secondary objectives. Louis, MO after that date, uniformly weighting the data. Continuous covariates including weight, age and body surface area were included in the model using power equations after centering on the median.
After dose selection, the study provided additional data on safety, efficacy, and population PK. In assessing medication compliance at each visit, the primary care giver completed an adherence questionnaire, and site personnel collected and counted the returned used study drug sachets to determine the total number used since the last visit. The unobserved C12hr plasma sample was collected between 11 and 13 hours after the prior unobserved raltegravir dose, and just before an observed dose. However, after evaluation of the Cohort V Stage I data and given the emergence of the importance of C12hr concentrations from the QDMRK study [ 5 , 6 ], it was determined that these data were required. Standard two-compartment structural models were explored with and without lag time, utilizing zero-order or first-order absorption, and log transforming the concentration data. Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. Louis, MO after that date, uniformly weighting the data. Three subjects discontinued study before 48 weeks. Cohort IV blood for PK analysis was drawn at predose, 0. The sparse PK samples were collected regardless of food at following time points: Pharmacokinetic Samples and Datasets Data included in this analysis comes from a formulation comparison study in adult healthy volunteers P 12 and the pediatric PK, safety and efficacy study in HIV-infected children P 4 , where in both studies the adult tablet, chewable tablet and GFS formulations were used. More details regarding the bioanalysis can be found in the previously published methods 13 , Blood samples for PK analyses were collected within 3 hours before study drug administration and at 0. This was done as a practical measure, as intensive PK was collected in between 8 and 12 subjects in each cohort, and thus criteria based on individual rather than mean values could be biased by a single outlier. An observed failure approach was used for handling missing data. At Week 48, gains in CD4 cells of Specifically, the model-estimated elimination rate constant for each individual was used with the last observed concentration at 8 hours to estimate the concentration at the hour time point. By the data freeze date March 17, , all subjects enrolled in Cohorts IV and V had been on study for at least 48 weeks; therefore, this report presents the safety and efficacy results of the complete week data. The intensive PK samples were collected fasted at predose, 0. We randomly assigned participants 2: Rizk Find articles by Matthew L. No treatment-related deaths were reported. Neither scored tablets nor chewable tablets can be used in infants and toddlers, because solid formulations are not appropriate due to immature chewing ability and the potential for choking. In P, healthy adult subjects received a single mg dose of raltegravir as the adult tablet, chewable tablets, or GFS formulation. These results reflect the age-specific doses proposed and approved for commercial use.
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