Preliminary Results of a Randomized Multicenter Study Comparing Combivir (ZDV/3TC) plus Nelfinavir or Nevirapine in HIV-Infected Naive Patients (COMBINE Study)

D. PODZAMCZER*¹, E. FERRER¹, E. CONSIGLIO¹, J. M. GATELL¹, J. PEREZ¹, J. L. PEREZ¹, L. LOZANO¹, A. GONZALEZ¹, R. SOLE¹, C. AZUAJE¹, J. M. LLIBRE¹, A. GONZALEZ¹, A. CASIRO², M. ARANDA¹, P. BARRUFET¹, J. M. LACASA¹, X. BADIA¹, P. CAHN², and S. LUPO². ¹Spain and ²Argentina

We present the preliminary results of a open randomized multicenter trial comparing combivir (ZDV 300 mg/3TC 150 mg bid) associated to nelfinavir 1250 mg bid (Group 1) or nevirapine 200 mg bid (Group 2). One hundred and forty three HIV-infected naive patients were recruited in 12 centers in Spain and Argentina. Thirty-eight percent had acquired HIV infection by drug use and 26% were women. Baseline median CD4 count was 364 (range: 10-992) cells/uL and median viral load (VL) (by  PCR test) 4.8 (range: 3.2-6.2) log10. One third of patients had VL > 100,000 copies/mL and 20% CD4 < 200/uL.  No differences in baseline characteristics were found between arms. Eighty-seven patients (43 in Gr. 1 and 44 in Gr. 2) reached at least 3 months of follow up. Of them, 28 (32%) had discontinued initial therapy (10 lost to follow-up, 16 switched due to adverse effects, and 2 voluntarily). In an intention-to-treat analysis at 12 weeks, 56% and 57% had  VL < 200 copies/mL, while in an on-treatment analysis 83% in both arms had VL < 200 copies/mL. No differences in virological response were observed between arms in patients with VL > 100,000 c/mL. CD4 cells  rose +75 cells/mL in Gr. 1 and +64 cells/mL in Gr. 2.
Preliminary data suggest that both arms have an equivalent virological and immunological response at short term, even in pts with high VL. Updated results, including ultrasensitive VL, will be presented.

Key Words: Combivir, Nelfinavir, Nevirapine

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