TY - JOUR
T1 - The effect of treatment intensification in HIV-infection
T2 - A study comparing treatment with ritonavir/saquinavir and ritonavir/saquinavir/stavudine
AU - Gisolf, Elisabeth H.
AU - Jurriaans, Suzanne
AU - Pelgrom, Jolanda
AU - Van Wanzeele, Filip
AU - Van der Ende, Marchina E.
AU - Brinkman, Kees
AU - Borst, Marie José
AU - De Wolf, Frank
AU - Japour, Anthony J.
AU - Danner, Sven A.
PY - 2000
Y1 - 2000
N2 - Objective: To evaluate the effect of treatment with ritonavir (RTV)/saquinavir (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 and 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. Intensification of study medication with reverse transcriptase inhibitors was permitted if 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 (CI), 54-73%] of subjects in the RTV/SQV group (n = 104) reached a serum HIV-RNA < 400 copies/ml at week 48, as compared with 69% (95% CI, 60-78%) in the RTV/SQV/D4T group (n = 104; P = 0.379). In the on-treatment analysis these percentages were 88 and 91% respectively. Thirty-one patients intensified their study medication 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 copies/ml at their last follow-up visit. Ten per cent of patients discontinued study medication due to adverse events. Conclusion: The concept of starting with a simple, potent regimen, that could be intensified if necessary, showed good virological results after 48 weeks in this study, comparable to starting with more drugs from the beginning. Longer follow-up is needed to determine the long-term efficacy of this treatment strategy. (C) 2000 Lippincott Williams and Wilkins.
AB - Objective: To evaluate the effect of treatment with ritonavir (RTV)/saquinavir (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 and 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. Intensification of study medication with reverse transcriptase inhibitors was permitted if 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 (CI), 54-73%] of subjects in the RTV/SQV group (n = 104) reached a serum HIV-RNA < 400 copies/ml at week 48, as compared with 69% (95% CI, 60-78%) in the RTV/SQV/D4T group (n = 104; P = 0.379). In the on-treatment analysis these percentages were 88 and 91% respectively. Thirty-one patients intensified their study medication 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 copies/ml at their last follow-up visit. Ten per cent of patients discontinued study medication due to adverse events. Conclusion: The concept of starting with a simple, potent regimen, that could be intensified if necessary, showed good virological results after 48 weeks in this study, comparable to starting with more drugs from the beginning. Longer follow-up is needed to determine the long-term efficacy of this treatment strategy. (C) 2000 Lippincott Williams and Wilkins.
KW - HIV
KW - Protease inhibitors
KW - Stavudine
KW - Treatment intensification
UR - http://www.scopus.com/inward/record.url?scp=0034077203&partnerID=8YFLogxK
U2 - 10.1097/00002030-200003100-00014
DO - 10.1097/00002030-200003100-00014
M3 - Article
C2 - 10770543
AN - SCOPUS:0034077203
VL - 14
SP - 405
EP - 413
JO - AIDS
JF - AIDS
SN - 0269-9370
IS - 4
ER -