• Poster 510: Preliminary Results of a Randomized Multicenter Study Comparing Combivir (ZDV/3TC) plus Nelfinavir or Nevirapine in HIV-Infected Naive Patients (COMBINE Study) (Authored by D. Podzamczer, E. Ferrer, E. Consiglio, J.M. Gatell, J. Perez, J.L. Perez, L. Lozano, A. Gonzalez, R. Sole, C. Azuaje, J.M. Llibre, A. Gonzalez, A. Casiro, M. Aranda, P. Barrufet, J.M. Lacasa, X. Badia, P. Cahn, and S. Lupo. Spain and Argentina)
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The COMBINE Trial from Argentina and Spain is another addition to the short list of head-to-head protease vs. protease-sparing regimens. In this trial, patients received combivir with either nevirapine or nelfinavir (1,250 mg twice/day). Six-month results were reported with approximately 70 patients in each arm.

The two arms had approximately the same rate of toxicity, drop out, and T-cell increase (75 cells over 6 months). However, viral load results were significantly better in the nevirapine group: 58% had a PCR <20 versus 33% in the nelfinavir arm (intent-to-treat analysis. Observed data was 80 vs. 45%). The difference was even more impressive in those with a high baseline (>100,000), with 57% <20 on nevirapine vs. 22% on nelfinavir (intent-to-treat).

Although this was a small trial with short follow-up, this trial demonstrates that a non-nucleoside RT inhibitor-based regimen can provide as good or better results than a protease inhibitor-based regimen, and given the reduced pill count and toxicity, it is a regimen that should definitely be considered in naive patients.