Abstract 327 - A Randomized, Open, Multicenter Trial Comparing Combivir plus Nelfinavir or Nevirapine in HIV-Infected Naive Patients (The Combine Study).

327 A Randomized, Open, Multicenter Trial Comparing Combivir plus Nelfinavir or Nevirapine in HIV-Infected Naive Patients (The Combine Study).

D. Podzamczer*, E. Ferrer, E. Consiglio, J. M. Gatell, P. Perez, J. L. Perez, E. Luna, A. Gonzalez, E. Pedrol, L. Lozano, C. Azuaje, J. M. Libre, A. Casiro, M. Aranda, P. Barrufet, J. M. Lacasa, X. Badia, A. Casado, S. Lupo, and P. Cahn.
Spain and Argentina.

Background:Our objective was to evaluate the efficacy and safety of two HAART regimens in HIV-infected naive pts.

Methods:Randomized, open, multicenter study comparing combivir (ZDV 300mg/3TC 150 mg bid) associated to nelfinavir 1250 mg bid (CNf) or nevirapine 200 mg bid (CNr) in 142 HIV-infected naive pts. recruited between November 1998 and August 1999 from 12 hospitals (9 in Spain and 3 in Argentina). Efficacy was assessed by intent-to-treat (ITT) (missing = failure) and on-treatment (OT) analysis.

Results:Baseline mean CD4 count was 359 (range 10—908) cells/mL, and mean viral load (VL, by PCR test) was 5.15 (3.2—6.2) log₁₀(median 4.78). One third of pts had VL >100,000 copies/ml and 20% CD4 <200/mL (no differences between arms). In an ITT analysis at 36 weeks, 55.7% (CNf) and 70.8% (CNr) had VL <200 c/ml (p = 0.06), while in an OT analysis 78.0% vs. 83.7% had VL <200 c/ml, respectively (p = 0.50). 38.6% (CNf) vs. 66.7% (CNr) had VL <20 c/ml by ITT analysis (p < 0.001) and 56.1% vs. 79.6% had VL <20 c/ml by OT analysis, respectively (p = 0.02). Even in pts with baseline VL >100,000 c/ml a higher proportion of CNr pts had VL <20 c/ml by ITT and OT analysis. An ITT exposed analysis (excluding 10 randomized pts (8 CNf, 2 CNr) who did not return to follow-up visits) showed again a better virological response in CNr arm when comparing VL <20 copies/ml (p = 0.0038). A gain of 172 (CNf) and 116 (CNr) CD4 cells/mL was observed (p = 0.57). About 20% of pts switched initial therapy due to adverse effects, being GI symptoms in CNf pts and hematologic toxicity, hepatitis and rash in CNr pts, the most frequent adverse events found.

Conclusions:Preliminary results of our study suggest that CNr may have greater efficacy than CNf. Both regimens have an acceptable tolerance. Final analysis (12 months) will be presented.