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A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection

Cardiello, Peter
Hassink, Elly
Ananworanich, Jintanat
Srasuebkul, Preeyaporn
Samor, Tarika
Mahanontharit, Apicha
Ruxrungtham, Kiat
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Published in Clinical infectious diseases. 2005, vol. 40, no. 4, p. 594-600
Abstract 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 > or =350 cells/microL 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 > or =350 cells/microL. 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 > or =350 cells/microL 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 > or =350 cells/microL 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.
Keywords AdultAnti-HIV Agents/ administration & dosage/therapeutic useAntiretroviral Therapy, Highly ActiveCD4 Lymphocyte CountChronic DiseaseDrug Administration ScheduleDrug Therapy, CombinationFemaleHIV Infections/ drug therapy/virologyHIV Protease Inhibitors/ administration & dosage/therapeutic useHiv-1HumansMaleProspective StudiesReverse Transcriptase Inhibitors/ administration & dosage/therapeutic useTreatment Outcome
PMID: 15712083
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CARDIELLO, Peter et al. A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection. In: Clinical infectious diseases, 2005, vol. 40, n° 4, p. 594-600. doi: 10.1086/427695 https://archive-ouverte.unige.ch/unige:7135

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Deposited on : 2010-06-21

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