Journal Article

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

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

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 40, issue 4, pages 594-600
Published in print February 2005 | ISSN: 1058-4838
Published online February 2005 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/427695
A Prospective, Randomized Trial of Structured Treatment Interruption for Patients with Chronic HIV Type 1 Infection

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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.

Journal Article.  3733 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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