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A
Pilot Trial of Indinavir, Ritonavir, Didanosine, and Lamivudine
in a Once-Daily Four-Drug Regimen for HIV Infection [Mole
L et al. JAIDS 2001;27:260]: This is a study from Stanford
using a once daily regimen consisting of ddI (400 mg at 30-60 minutes
before meal) and then a post-meal regimen of indinavir, 1200 mg,
ritonavir, 400 mg and 3TC, 300 mg. There were 10 participants including
9 who completed 24 weeks of study. The authors reported that the
regimen was well tolerated, and 8 (80%) achieved a viral load of
<50 c/mL by week 12 and a median CD4 cell count increase of 193/mm3.
Plasma concentrations remained above the IC95
for the 24-hour dosing interval in 6 of 10 for indinavir and 8 of
10 for ritonavir. The authors conclude that this pilot study demonstrates
the potential for excellent viral suppression with a once-daily
regimen.
Comment: This trial is similar to others attempting a once-daily
regimen except for the relatively high dose of ritonavir. Concerns
with this regimen include the marked changes in the lipid profile
with a median increase in cholesterol levels of 49% and a median
increase in triglyceride levels of 108%. There will also be concerns
about the inconvenience of splitting the dosing of ddI with the
rest of the regimen, possible intolerance of ritonavir with a 400
mg dose, and about possible nephrolithiasis with the 1200 mg dose
of indinavir. Nevertheless, the virologic outcome, the CD4 cell
response, and the pharmacokinetic profiles all looked good.
posted
8/14/2001
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