The effect of treatment intensification in HIV-infection: a study comparing treatment with ritonavir/saquinavir and ritonavir/saquinavir/stavudine

Objective: To evaluate the effect of treatment with ritonavir (RTV)/saquina vir (SQV)/stavudine (D4T) or RTV/SQV alone, with treatment intensification if needed, in protease inhibitor- and D4T-naive HIV-1-infected individuals. Design: Multicentre, open-label, randomized controlled trial. Two-hundred a nd eight patients were randomized to receive treatment with RTV 400 mg/SQV 400 mg twice daily or RTV 400 mg/SQV 400 mg/D4T 40 mg twice daily. Intensif ication of study medication with reverse transcriptase inhibitors was permi tted ii serum HIV-RNA remained > 400 copies/ml after 12 weeks of treatment. Follow-up of this study was 48 weeks. Results: In a strict intention-to-treat analysis, counting all dropouts as virological failures, 63% [95% confidence interval (Cl), 54-73%] of subject s in the RTV/SQV group (n = 104) reached a serum HIV-RNA ( 400 copies/ml at week 48, as compared with 69% (95% Cl, 60-78%) in the RTV/SQV/D4T group in = 104; P = 0.379). In the on-treatment analysis these percentages were 88 and 91% respectively. Thirty-one patients intensified their study medicatio n according to the protocol (28 in the RTV/SQV group, three in the RTV/SQV/ D4T group). Thirty out of 31 (97%) patients had a serum HIV-RNA ( 400 copie s/ml at their last follow-up visit. Ten per cent of patients discontinued s tudy medication due to adverse events. Conclusion: The concept of starting with a simple, potent regimen, that cou ld be intensified if necessary, showed good virological results after 48 we eks in this study, comparable to starting with more drugs from the beginnin g. Longer follow-up is needed to determine the long-term efficacy of this t reatment strategy. (C) 2000 Lippincott Williams & Wilkins.