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 NCT00100646
Highlights
Antiretroviral Therapy (ART) is available in resource-constrained countries through governmental and international funding programs, which have begun to impact the survival of communities [1]
A second study evaluating structured interruptions in Corte d’Ivoire (TRIVACAN study [10]) assessed three scheduled interruptions of 2 months each followed by 4 months of continuous ART (c-ART) compared with continuous NNRTI-based ART in subjects with a median pre-ART CD4+ T cell count nadir of 272 cells/ml
Participants’ clinical and demographic characteristics Between July 2005 and July 2009, 116 participants were initially enrolled into the study and initiated ART
Summary
Antiretroviral Therapy (ART) is available in resource-constrained countries through governmental and international funding programs, which have begun to impact the survival of communities [1]. A second study evaluating structured interruptions in Corte d’Ivoire (TRIVACAN study [10]) assessed three scheduled interruptions of 2 months each followed by 4 months of continuous ART (c-ART) compared with continuous NNRTI-based ART in subjects with a median pre-ART CD4+ T cell count nadir of 272 cells/ml. While the interruption arm was considered to be non-inferior, there was a significantly higher rate of resistance to non-nucleotides (NNRTIs) in the experimental arm. Both SMART and TRIVACAN had low retreatment thresholds (CD4+ T cell count ,250 cells/ml), exposing subjects to prolonged periods of immunodeficiency. The clinical outcomes of short interruptions of PI-based ART regimens remains undefined
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