Indinavir, Nevirapine, Stavudine, and Lamivudine for Human Immunodeficiency Virus-Infected, Amprenavir-Experienced Subjects: AIDS Clinical Trials Group Protocol 373 [[Gulick RM, et al. JID 2001;183:715]: This is an ACTG open-label study to determine the feasibility of changing from an amprenavir-based HAART regimen to indinavir (1000 mg q8h), nevirapine (200 mg bid), d4T (40 mg bid), and 3TC (150 mg bid). The median duration of amprenavir was 16 weeks, and the median viral load was 15,649 c/mL. Analysis at 48 weeks showed that 33 of 56 participants had viral loads <500 c/mL (59%), and the median CD4 cell count increase was 94/mm³. The authors concluded that most patients who have received amprenavir-based treatment can be changed to a four-drug regimen and achieve durable viral suppression.
Comment: The intent of the study was to determine the feasibility of changing regimens with particular interest in the potential benefit of amprenavir as the initial PI based on the observation that the resistance profile of this drug does not overlap with that of other PIs. Thus, amprenavir, like nelfinavir, has the potential advantage of better likelihood of success with rescue treatment when used initially. The present study supports this concept for amprenavir, but there are some limitations: It was a non-randomized study, the sample size was relatively modest, some of the amprenavir recipients had received this drug as monotherapy, which would not match practice standards at present, and some (9%) had viral loads <500 c/mL at baseline, suggesting probable success with continuation on the initial regimen. Finally, many would make the decision regarding the next regimen on the basis of resistance testing, which was not done in this report.
posted 3/29/2001

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