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- Title
Pharmacokinetics and short-term efficacy of a double-boosted protease inhibitor regimen in treatment-naive HIV-1-infected adults.
- Authors
Jasper van der Lugt; Reshma Saskia Autar; Sasiwimol Ubolyam; Evian Fernandez Garcia; Jongkol Sankote; Anchalee Avihingson; Theshinee Chuenyam; David A. Cooper; Joep Lange; Praphan Phanuphak; Ferdinand Wit; Kiat Ruxrungtham; David Burger; on behalf of the HIV-NAT 019 Study Team
- Abstract
: Objectives To study the pharmacokinetics and short-term efficacy of low and standard dose lopinavir/ritonavir and saquinavir combinations in Thai, human immunodeficiency virus (HIV)-infected, treatment-naive patients. : Methods In this open-label, 24-week, prospective study, 48 treatment-naive patients were randomized to lopinavir/ritonavir 400/100 mg+saquinavir 1000 mg twice daily (arm A), lopinavir/ritonavir 400/100 mg+saquinavir 600 mg twice daily (arm B), lopinavir/ritonavir 266/66 mg+saquinavir 1000 mg twice daily (arm C), or lopinavir/ritonavir 266/66 mg+saquinavir 600 mg twice daily (arm D). A 12 h. pharmacokinetic profile in all patients was performed. Plasma concentrations of saquinavir and lopinavir were determined using an HPLC technique. HIV-1 RNA was measured over 24 weeks. : Results Forty-three subjects were included in the pharmacokinetic analysis. The total exposure differed significantly for the different arms. Median values for lopinavir area under the curve at 0–12 h were 128.2, 119.2, 66.1 and 68.5 mg·h/L for arms A–D, respectively. For saquinavir, the median values were 36.9, 19.2, 25.3 and 12.4 mg·h/L for arms A–D, respectively. The proportion of patients having a viral load below 50 copies/mL at week 24 was 39% for arm A, 63% for arm B, 55.0% for arm C, and 69% for arm D. : Conclusions The pharmacokinetic parameters for the different treatment arms were adequate. However, the proportion of subjects with an undectable viral load at week 24 was lower than anticipated.
- Subjects
GEL permeation chromatography; HIV-positive persons; CHEMICAL kinetics; NUCLEIC acids
- Publication
Journal of Antimicrobial Chemotherapy (JAC), 2008, Vol 61, Issue 5, p1145
- ISSN
0305-7453
- Publication type
Article