Shelton M, Morse G, DeRemer M, Adams J, Grasela T, Hewitt R; International Conference on AIDS.
Int Conf AIDS. 1993 Jun 6-11; 9: 503 (abstract no. PO-B30-2207).
State Univ. of New York, Buffalo.
The paucity of pharmacokinetic (PK) data for zalcitabine (ddC) at doses < or = 0.75 mg prompted a PPK evaluation of ddC in our HIV population. Questionnaires were completed by patients to determine dosing histories, and plasma was collected whenever blood samples were ordered for routine patient care. ddC concentrations were determined by radioimmunoassay (sensitivity approximately 0.5 ng/ml), and PPK parameter estimates were derived from NONMEM. Preliminary results from 25 patients (24 male, 1 female) receiving ddC monotherapy (n = 5) or ddC/ZDV combination therapy (n = 20) for 173 +/- 144 days are available. Patients were 38 +/- 7 years of age, with mean serum creatinine of 1.01 +/- 0.14 mg/dl. ddC regimens ranged from 0.1875 mg every 24 hours to 0.75 mg every 8 hours. 1-9 samples/patient were collected 0.5-17 h after dosing. ddC was detectable in all samples, with concentrations ranging from 0.54-8.3 ng/ml. Using a one compartment PK model, mean (CV) population Cl/F approximately 0.19 (7.5%) L/h/kg and Vd/F approximately 2.4 (22%) L/kg. Cl/F estimates agree with studies using higher doses, but Vd/F is larger and more variable. Effects of food and concurrent ZDV on ddC PPK, and alternative PK models are under evaluation.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Female
- HIV Infections
- HIV Seropositivity
- Humans
- Longitudinal Studies
- Male
- Models, Biological
- Population
- Population Groups
- Prospective Studies
- Radioimmunoassay
- Zalcitabine
- Zidovudine
- methods
- pharmacokinetics
Other ID:
UI: 102205211
From Meeting Abstracts