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Therapy
of Efavirenz Plus Indinavir in Patients with Extensive Prior Nucleoside
Reverse Transcriptase Inhibitor Experience: A Randomized, Double-Blind,
Placebo Controlled Trial [Haas DW, et al. JID 2001;183:392]:
This is a
clinical trial comparing EFV plus IDV (1000 mg q8h) versus IDV (800
mg q8h) alone in 327 NRTI-experienced patients. The study drugs
were combined with NRTIs, participants had a mean duration of prior
NRTI treatment of 2.8 years, and baseline VL levels were >10,000
c/mL. Analysis at 24 weeks showed that the number with VL <400
c/mL was 68% in the EFV/IDV group compared to 52.4% in the group
receiving IDV alone (p = 0.004). These results were sustained to
48 weeks.
Comment: These results are similar to those achieved in DuPont
006 with efavirenz versus indinavir, each with AZT plus 3TC, in
treatment-naïve patients. Thus, the major question concerns
the need for two new classes in patients with virologic failure
because of extensive NRTI exposure.
posted
3/8/2001

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