Veldkamp A, Van Heeswyk RP, Scherpbier HJ, De Koning LA, Beynen JH, Heymans HS, Lange JM, Hoetelmans RM; International Conference on AIDS.

Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. WePeB4124.

A. Veldkamp, Slotervaart Hospital Dept Pharmacy, Louwesweg 6, 1066 Amsterdam, Netherlands, Tel.: +312 051 244 81, Fax: +312 051 247 53, E-mail: Apabg@slz.nl

Objective: To assess the steady-state pharmacokinetics (PK) of lamivudine and stavudine in HIV-1-infected children. Methods: In 16 HIV-1-infected children (age 1-155 months, weight 3.8-30 kg, 8 male, 8 female), who are treated with stavudine (1 mg/kg twice daily), and lamivudine (4 mg/kg twice daily) as part of a triple drug regimen (lamivudine, stavudine, and nelfinavir), steady-state PK of stavudine and lamivudine were determined after at least one week of therapy by drawing 12 blood samples during a dosing interval. Stavudine and lamivudine concentrations in plasma were quantified with validated and sensitive HPLC-assays. Plasma concentration (C) - time (T) data were analyzed by noncompartmental methods. The terminal, log-linear period (log C versus T) was defined by the last data points (N (3) 3) by visual inspection. The absolute value of the slope (b ln10) was calculated by least squares analysis. The elimination half-life (t1/2 ) was calculated using the equation t1/2 = ln2/b . The following pharmacokinetic parameters were also determined: the area under the plasma concentration versus time curve (AUC [0-12 h] ), the minimum and maximum plasma concentration (Cmin and Cmax ), and the time to Cmax (Tmax ). Results: Lamivudine Stavudine Parameter Median IQR Median IQR AUC[0-12 h] (h* m g/mL) 7.14 5.52-9.26 2.81 1.12-12.77 Cmax (m g/mL) 2.21 1.29-3.45 0.81 0.53-2.45 Cmin (m g/mL) 0.07 0.04-0.10 0.08 >0.01-0.35 Tmax (h) 1.17 0.75-1.90 1.00 0.69-1.81 t1/2 (h) 2.25 1.90-2.96 2.51 0.95-4.98 Conclusions: The steady-state pharmacokinetics of lamivudine and stavudine when combined with nelfinavir in pediatric HIV-1-infected patients are similar to those reported in single dose pharmacokinetic studies in the same population.

Publication Types:

• Meeting Abstracts

Keywords:

• Area Under Curve
• Child
• Chromatography, High Pressure Liquid
• Female
• HIV-1
• Humans
• Lamivudine
• Male
• Nelfinavir
• Stavudine
• pharmacokinetics

Other ID:

• GWAIDS0002843

UI: 102240337

From Meeting Abstracts