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Title

A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients

Authors
Ananworanich, Jintanat
Hill, Andrew
Siangphoe, Umaporn
Ruxrungtham, Kiat
Prasithsirikul, Wisit
Chetchotisakd, Ploenchan
Kiertiburanakul, Sasisopin
Munsakul, Warangkana
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Published in Antiviral Therapy. 2005, vol. 10, no. 6, p. 761-767
Abstract OBJECTIVE: 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/microl and HIV RNA 50 118 (4.7 log10) copies/mi. 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/microl. 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.
Keywords AdultAnti-HIV Agents/administration & dosage/adverse effects/therapeutic useAntiretroviral Therapy, Highly Active/ adverse effectsCD4 Lymphocyte CountDrug Therapy, CombinationFemaleHIV Infections/ drug therapy/virologyHIV-1/drug effectsHumansMaleProspective StudiesRNA, Viral/bloodReverse Transcriptase Inhibitors/administration & dosage/adverseEffects/ therapeutic useRitonavir/administration & dosage/adverse effects/therapeutic useSaquinavir/administration & dosage/adverse effects/therapeutic useThailandTreatment Outcome
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PMID: 16218176
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ANANWORANICH, Jintanat et al. A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients. In: Antiviral Therapy, 2005, vol. 10, n° 6, p. 761-767. https://archive-ouverte.unige.ch/unige:7079

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Deposited on : 2010-06-21

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