Litalien C, Ciaquinto C, Faye A, Mechinaud F, Grosch I, Compagnucci A, Jacqz-Aigrain E; International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. MoPeB2213.
C. Litalien, Hopital Robert Debre, 48 Boulevard Serurier, 75019 Paris, France, Tel.: +33 1 40 03 21 50, Fax: +33 1 40 03 47 59, E-mail: evelyne.jacqz-aigrain@rdb.ap-hop-paris.fr
Backgound: Perinatally infected infants with very high viral load in the first months of life appear to be at increased risk for a rapid progression of disease and early antiretroviral treatment is recommended. Pharmacokinetics (PK), efficacy and tolerance of Nelfinavir given with Didanosine and Stavudine in infants less than 3 months old are being currently evaluated in a multicenter study. Nelfinavir steady state PK from the first 4 patients receiving 40 mg/kg/dose three times a day (120 mg/kg/day) are presented. Methods: Blood samples (n = 6) were obtained from each patient. Plasma Nelfinavir concentrations were measured by HPLC-MS and individual PK parameters were determined. Results: The three patients less than 4 months old had Cmin (783, 406 and 248 ng/ml) and AUC0-8 (10627, 8053 and 8930 m gx hr/L) well below the desired levels in older children and adults (Cmin of 1500 ng/ml and AUC0-8 of 18000 to 20000 m gx hr/L). The fourth patient, who was 6 months old, achieved therapeutic levels (Cmin of 1416 ng/ml and AUC0-8 of 17429 ngx hr/L) with the same dosing regimen. Conclusions: These results suggest that Nelfinavir requirements in very young infants are higher than in older children and adults, most likely secondary to decreased Nelfinavir bioavailability in this age group. We are currently evaluating Nelfinavir PK in infants less than 3 months old receiving 75 mg/kg/dose twice daily (150 mg/kg/day).
Publication Types:
Keywords:
- Adult
- Child
- Chromatography, High Pressure Liquid
- Didanosine
- Humans
- Infant
- Nelfinavir
- Stavudine
- Viral Load
Other ID:
UI: 102237813
From Meeting Abstracts