Randomized trial of time-limited interruptions of protease inhibitor-based antiretroviral therapy (ART) vs. continuous therapy for HIV-1 infection |
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Authors: | Firnhaber Cynthia Azzoni Livio Foulkes Andrea S Gross Robert Yin Xiangfan Van Amsterdam Desiree Schulze Doreen Glencross Deborah K Stevens Wendy Hunt Gillian Morris Lynn Fox Lawrence Sanne Ian Montaner Luis J |
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Institution: | Clinical HIV Research Unit, Faculty of Health Sciences, Department of Medicine, University of the Witwatersrand, Johannesburg, South Africa. |
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Abstract: | BackgroundThe clinical outcomes of short interruptions of PI-based ART regimens remains undefined.MethodsA 2-arm non-inferiority trial was conducted on 53 HIV-1 infected South African participants with viral load <50 copies/ml and CD4 T cell count >450 cells/µl on stavudine (or zidovudine), lamivudine and lopinavir/ritonavir. Subjects were randomized to a) sequential 2, 4 and 8-week ART interruptions or b) continuous ART (cART). Primary analysis was based on the proportion of CD4 count >350 cells(c)/ml over 72 weeks. Adherence, HIV-1 drug resistance, and CD4 count rise over time were analyzed as secondary endpoints.ResultsThe proportions of CD4 counts >350 cells/µl were 82.12% for the intermittent arm and 93.73 for the cART arm; the difference of 11.95% was above the defined 10% threshold for non-inferiority (upper limit of 97.5% CI, 24.1%; 2-sided CI: ?0.16, 23.1). No clinically significant differences in opportunistic infections, adverse events, adherence or viral resistance were noted; after randomization, long-term CD4 rise was observed only in the cART arm.ConclusionWe are unable to conclude that short PI-based ART interruptions are non-inferior to cART in retention of immune reconstitution; however, short interruptions did not lead to a greater rate of resistance mutations or adverse events than cART suggesting that this regimen may be more forgiving than NNRTIs if interruptions in therapy occur.Trial RegistrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00100646","term_id":"NCT00100646"}}NCT00100646 |
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