Jintanat AnanworanichAndrew HillUmaporn SiangphoeKiat RuxrungthamWisit PrasithsirikulPloenchan ChetchotisakdSasisopin KiertiburanakulWarangkana MunsakulPhitsanu RaksakulkarnSomboon TansuphasawadikulReto NueschDavid A. CooperBernard HirschelThe HIV Netherlands Australia Thailand Research CollaborationUniversity of LiverpoolChulalongkorn UniversityBamrasnaradura Infectious Disease InstituteKhon Kaen UniversityMahidol UniversityVajira HospitalSan Pa Tong HospitalBuddhachinnaraj HospitalUniversitatsspital BaselKirby InstituteHopitaux universitaires de Geneve2018-06-212018-06-212005-10-06Antiviral Therapy. Vol.10, No.6 (2005), 761-767135965352-s2.0-25444499748https://repository.li.mahidol.ac.th/handle/20.500.14594/16783Objective: To assess the efficacy and safety of first-line treatment with once-daily saquinavir/ritonavir with two nucleoside reverse transcriptase inhibitors (NRTIs), as induction therapy before enrollment in a randomized trial of structured treatment interruption strategies. Design: Two-hundred antiretroviral-naive patients with CD4+ cell counts between 200-350 at screening were enrolled in this open-label 24week study. Methods: Patients were followed up every 8 weeks for CD4+ cells, HIV RNA, and clinical and laboratory toxicities. Results: Two-hundred patients were enrolled with median baseline CD4+ cell count of 267 cells/μl and HIV RNA 50 118 (4.7 log10) copies/ml. After 24 weeks of treatment, 191 of 200 (96%) patients had below 400 copies/ml HIV RNA, with 177/200 (89%) below 50 copies/ml (intent to treat, missing equals failure method), with a median rise in CD4+ cell count of 122 cells/μl. There was no significant correlation between the minimum concentration of saquinavir and HIV RNA reductions at week 8 (P=0.957) or absolute HIV RNA at week 24 (P=0.77). Conclusion: First-line highly active antiretroviral therapy (HAART) with once-daily saquinavir/ritonavir plus two NRTIs showed strong antiviral efficacy over 24 weeks, and should be evaluated in larger prospective randomized clinical trials. © 2005 International Medical Press.Mahidol UniversityMedicinePharmacology, Toxicology and PharmaceuticsArticleSCOPUS