A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
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Date
2010
Journal Title
Journal ISSN
Volume Title
Publisher
PLoS One
Abstract
Short cycle treatment interruption could reduce toxicity and drug costs and contribute to further expansion of
antiretroviral therapy (ART) programs.
A 72 week, non-inferiority trial enrolled one hundred forty six HIV positive persons receiving ART (CD4+ cell count
$125 cells/mm3 and HIV RNA plasma levels ,50 copies/ml) in one of three arms: continuous, 7 days on/7 days off and 5
days on/2 days off treatment. Primary endpoint was ART treatment failure determined by plasma HIV RNA level, CD4+ cell
count decrease, death attributed to study participation, or opportunistic infection.
Following enrollment of 32 participants, the 7 days on/7 days off arm was closed because of a failure rate of 31%.
Six of 52 (11.5%) participants in the 5 days on/2 days off arm failed. Five had virologic failure and one participant had
immunologic failure. Eleven of 51 (21.6%) participants in the continuous treatment arm failed. Nine had virologic failure with
1 death (lactic acidosis) and 1 clinical failure (extra-pulmonary TB). The upper 97.5% confidence boundary for the difference
between the percent of non-failures in the 5 days on/2 days off arm (88.5% non-failure) compared to continuous treatment
(78.4% non failure) was 4.8% which is well within the preset non-inferiority margin of 15%. No significant difference was
found in time to failure in the 2 study arms (p = 0.39).
Short cycle 5 days on/2 days off intermittent ART was at least as effective as continuous therapy
Description
Keywords
HIV Infection, Antiretroviral Therapy, Trial of Short Cycle Intermittent
Citation
Reynolds, S. J., Kityo, C., Hallahan, C. W., Kabuye, G., Atwiine, D., Mbamanya, F., ... & Dybul, M. R. (2010). A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One, 5(4), e10307.https://doi.org/10.1371/journal.pone.0010307