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Title: A randomized, open-label, comparative trial of zidovudine plus lamivudine versus zidovudine plus lamivudine plus didanosine in antiretroviral-naive HIV-1-infected Thai patients
Authors: Chaiwat Ungsedhapand
Eugene D.M.B. Kroon
Surapol Suwanagool
Kiat Ruxrungtham
Nongluk Yimsuan
Areerat Sonjai
Sasiwimol Ubolyam
Supranee Buranapraditkun
Surapee Tiengrim
Nadine Pakker
Chaiyos Kunanusont
Joep M.A. Lange
David A. Cooper
Praphan Phanuphak
The HIV Netherlands Australia Thailand Research Collaboration
Academic Medical Centre, University of Amsterdam
Mahidol University
Chulalongkorn University
Thailand Ministry of Public Health
Kirby Institute
Keywords: Medicine
Issue Date: 1-Jun-2001
Citation: Journal of Acquired Immune Deficiency Syndromes. Vol.27, No.2 (2001), 116-123
Abstract: Objective: To assess the efficacy and tolerability of a triple nucleoside reverse transcriptase inhibitor combination of zidovudine, lamivudine, and didanosine therapy. Design: A randomized open-label trial. Patients: Antiretroviral-naive HIV-infected patients with CD4+cell counts of 100 to 500 cells/μl. Methods: A total of 106 patients were randomly assigned to 300 mg of zidovudine (200 mg for body weight <60 kg) twice daily plus 150 mg of lamivudine twice daily plus 200 mg of didanosine (125 mg for body weight <60 kg) twice daily (n = 53) or to zidovudine plus lamivudine (n = 53) for 48 weeks. Main Outcome Measures: Degree and duration of reduction of HIV-1 RNA load and increase in CD4+cell counts from baseline and development of drug-related toxicities. Results: At 48 weeks, triple drug therapy showed greater declines in plasma HIV-RNA levels from the beginning of treatment than double drug therapy (1.86 vs. 1.15 log10copies/ml, respectively; p < .001). The proportions of patients with HIV-RNA <50 copies/ml in an intention-to-treat analysis were 54.7% (29 of 53 patients) and 11.3% (6 of 53 patients) in the triple and double drug therapy, respectively (p = .001). There was no significant difference in increase of CD4 count. Conclusion: Triple drug therapy with zidovudine, lamivudine, and didanosine was significantly more effective in inducing sustained immunologic and virologic responses than the double combination of zidovudine and lamivudine.
ISSN: 15254135
Appears in Collections:Scopus 2001-2005

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