Objective: To determine prospectively the impact of switching treatment-experienced patients with virologic failure to a salvage regimen with or without a 12-week structured treatment interruption (STI). The primary endpoint was the percentage of patients with a 3-month sustained HIV RNA level <50 copies/mL.
Methods: A randomized, open-label, multicenter trial. At least 2 new antiretroviral (ARV) drugs, based on patient history, were included in the salvage regimen, as determined before randomization and guided by resistance testing.
Results: A total of 147 patients were randomized: 79 to the immediate switch (IS) arm and 68 to the STI arm. Success was achieved by 64% in the IS arm and 51% in the STI arm (95% confidence interval for the difference from 5% in favor of STI to 30% in favor of IS). During the STI, the median decrease in CD4 count was 80 cells/mm and the increase in viral load was 0.8 log10 copies/mL. There were no differences in median CD4 cell counts or HIV RNA levels at week 60. Two unrelated deaths (1 in each arm) and 3 AIDS-defining events (in the STI arm) occurred.
Conclusion: A 12-week STI before the initiation of salvage ARV therapy did not increase the proportion of patients with 3 months of sustained suppression of HIV RNA to <50 copies/mL.