A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
dc.contributor.author | Reynolds, Steven J. | |
dc.contributor.author | Kityo, Cissy | |
dc.contributor.author | Kabuye, Geoffrey | |
dc.contributor.author | Atwiine, Diana | |
dc.contributor.author | Mbamanya, Frank | |
dc.contributor.author | Ssali, Francis | |
dc.contributor.author | Davey, Richard T. | |
dc.contributor.author | Mugyenyi, Peter | |
dc.contributor.author | Fauci, Anthony S. | |
dc.contributor.author | Dybul, Mark R. | |
dc.date.accessioned | 2023-03-30T11:12:27Z | |
dc.date.available | 2023-03-30T11:12:27Z | |
dc.date.issued | 2010 | |
dc.description.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 | en_US |
dc.identifier.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 | en_US |
dc.identifier.uri | https://nru.uncst.go.ug/handle/123456789/8336 | |
dc.language.iso | en | en_US |
dc.publisher | PLoS One | en_US |
dc.subject | HIV Infection | en_US |
dc.subject | Antiretroviral Therapy | en_US |
dc.subject | Trial of Short Cycle Intermittent | en_US |
dc.title | A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda | en_US |
dc.type | Article | en_US |
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