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

dc.contributor.authorReynolds, Steven J.
dc.contributor.authorKityo, Cissy
dc.contributor.authorKabuye, Geoffrey
dc.contributor.authorAtwiine, Diana
dc.contributor.authorMbamanya, Frank
dc.contributor.authorSsali, Francis
dc.contributor.authorDavey, Richard T.
dc.contributor.authorMugyenyi, Peter
dc.contributor.authorFauci, Anthony S.
dc.contributor.authorDybul, Mark R.
dc.date.accessioned2023-03-30T11:12:27Z
dc.date.available2023-03-30T11:12:27Z
dc.date.issued2010
dc.description.abstractShort 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 therapyen_US
dc.identifier.citationReynolds, 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.0010307en_US
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/8336
dc.language.isoenen_US
dc.publisherPLoS Oneen_US
dc.subjectHIV Infectionen_US
dc.subjectAntiretroviral Therapyen_US
dc.subjectTrial of Short Cycle Intermittenten_US
dc.titleA Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Ugandaen_US
dc.typeArticleen_US
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