A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda

作者：Reynolds Steven J^*; Kityo Cissy; Hallahan Claire W; Kabuye Geoffrey; Atwiine Diana; Mbamanya Frank; Ssali Francis; Dewar Robin; Daucher Marybeth; Davey Richard T Jr; Mugyenyi Peter; Fauci Anthony S; Quinn Thomas C; Dybul Mark R

来源：PLos One, 2010, 5(4): e10307.

DOI：10.1371/journal.pone.0010307

Background: Short cycle treatment interruption could reduce toxicity and drug costs and contribute to further expansion of antiretroviral therapy (ART) programs.
Methods: A 72 week, non-inferiority trial enrolled one hundred forty six HIV positive persons receiving ART (CD4+ cell count >= 125 cells/mm(3) 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.
Results: 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).
Conclusions: Short cycle 5 days on/2 days off intermittent ART was at least as effective as continuous therapy.

• 出版日期2010-4-22
• 单位NIH