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A Prospective, Randomized Trial of Structured Treatment Interruption for Patients with Chronic HIV Type 1 Infection

Cardiello, Peter G. ; Hassink, Elly ; Ananworanich, Jintanat ; Srasuebkul, Preeyaporn ; Samor, Tarika ; Mahanontharit, Apicha ; Ruxrungtham, Kiat ; Hirschel, Bernard ; Lange, Joep ; Phanuphak, Praphan ; Cooper, David A.

In: Clinical Infectious Diseases, 2005, vol. 40, no. 4, p. 594-600

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    Titre
    • A Prospective, Randomized Trial of Structured Treatment Interruption for Patients with Chronic HIV Type 1 Infection
    Auteur
    • Cardiello, Peter G.. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Hassink, Elly. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Ananworanich, Jintanat. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Srasuebkul, Preeyaporn. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Samor, Tarika. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Mahanontharit, Apicha. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Ruxrungtham, Kiat. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Hirschel, Bernard. University Hospital of Geneva, Switzerland
    • Lange, Joep. International Antiviral Therapy Evaluation Center, Academic Medical Center, University of Amsterdam, The Netherlands
    • Phanuphak, Praphan. The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, and Chulalongkorn University, Bangkok, Thailand
    • Cooper, David A.. National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Clinical Infectious Diseases, 2005, vol. 40, no. 4, p. 594-600. The University of Chicago Press
    Autre version électronique
    Classification
    • Santé
    Identifiant OAI-PMH
    • oai:doc.rero.ch:293724
    Summary
    Background. Structured treatment interruption was evaluated in 74 patients who had been pretreated with antiretrovirals, consisting of 2 nucleoside reverse-transcriptase inhibitors (NRTIs) for 1 year followed by 3 years of highly active antiretroviral therapy containing a protease inhibitor. Methods. Patients with a CD4 cell count of ⩾350 cells/µL and a plasma viral load of <50 copies/mL were randomized to 3 therapy arms: (1) continuous therapy, (2) CD4 cell count—guided theory, and (3) week-on/week-off (WOWO) therapy. The efficacy and safety of structured treatment interruption and antiretroviral use were evaluated in human immunodeficiency type 1 (HIV-1)—infected patients. The study end points were percentage of patients who developed AIDS or who died and a CD4 cell count of ⩾350 cells/µL. Intergroup differences were analyzed using analysis of variance and Kruskal-Wallis tests. Results. Baseline characteristics at the start of the structured treatment interruption were similar. At week 48, no patient had died, and 1 patient in the WOWO group had an AIDS-defining condition. The proportions of patients with a CD4 cell count of ⩾350 cells/µL were 100%, 87%, and 96% in treatment arms 1, 2, and 3, respectively. The percentages of weeks of antiretroviral use were 100%, 41.1%, and 69.8% in arms 1, 2, and 3, respectively. The adverse events were not significantly different among arms (P = .27). Thirty-one percent of patients in the WOWO group experienced virological failure. Conclusion. WOWO therapy maintained a CD4 cell count of ⩾350 cells/µL in almost all patients but was associated with high virological failures rates (possibly resulting from previous dual-NRTI therapy), indicating that this strategy is less useful. Receipt of CD4 cell count—guided therapy resulted in comparable clinical outcomes to continuous therapy and may save antiretroviral-associated costs, but this needs to be confirmed by a larger trial