14th International AIDS Conference Barcelona, Spain — July 7-12, 2002

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. TuOrB1186

BACKGROUND: The use of HAART combining 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) + one protease inhibitor (PI) or 2 NRTIs + 1 non-nucleoside reverse transcriptase inhibitors (NNRTIs) has shown comparable efficacy and safety profile. However, the relevance of the selection of one starting regimen or the other remains unclear in the long term. The study was designed to compare long term (2 years) risk/benefit of two antiretroviral (ARV) treatment strategies in naïve patients: PI-based HAART switching to nevirapine in case of failure or the reverse sequence.

METHODS: This multicenter, randomized, open label clinical trial enrolled ARV-naïve patients with CD4 below 500 cells/mm³. They were randomly assigned to HAART containing either ddI+d4T+nelfinavir (NFV) switching to ZDV+3TC+NEV (PI-NEV arm) or ddI+d4T+nevirapine (NEV), switching to ZDV+3TC+NFV (NEV-PI arm). The primary study endpoints were the time until failure of the 2nd regimen and the proportion of patients with HIV RNA below 200 copies/mL.

RESULTS: A total of 140 patients were evaluable (67 and 73 in the PI-NEV and NEV-PI arms respectively). Baseline characteristics did not differ among groups. After 12 months, the proportions of patients with plasma HIV-1 RNA below 200 copies/mL were 94% and 88% respectively in the PI-NEV an NEV-PI arms (on-treatment analysis, P=0.32) and 73% and 68% in the intent-to-treat analysis (P=0.58). The mean increase in CD4+ count at 12 months was similar in both groups: +170 and +187 in the PI-NEV and NEV-PI arms respectively (P=0.3). A similar proportion of patients discontinued the first regimen due to virological failure (9 (13%) (PI-NEV) and 11 (15%) (NEV-PI), P=0.81) or adverse events (13 (19%) (PI-NEV) and 16 (22%) (NEV-PI), P=0.83).

CONCLUSIONS: Preliminary data at 12 months suggest that the strategies of PI-containing or NEV-based HAART show comparable efficacy and tolerability in naïve HIV-infected patients. Results after 18 months will be presented.

Presenting author: Mallolas, J.

1Hospital Clinic-IDIBAPS, Infectious Diseases Service, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain

2Hospital La Paz, Madrid, Spain

3Hospital Mutua de Terrassa, Terrassa, Spain

4Hospital Joan XXIII, Tarragona, Spain

5Hospital Son Dureta, Palma de Mallorca, Spain

6Hospital Parc Taulí, Sabadell, Spain

7Hospital de Granollers, Granollers, Spain

8Hospital Arnau de Vilanova, Valencia, Spain

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TuOrB1186

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.