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SESOTHO trial (“Switch Either near Suppression Or THOusand”) – switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa

Type of publication Peer-reviewed
Publikationsform Original article (peer-reviewed)
Author Amstutz Alain, Nsakala Bienvenu Lengo, Vanobberghen Fiona, Muhairwe Josephine, Glass Tracy Renée, Achieng Beatrice, Sepeka Mamorena, Tlali Katleho, Sao Lebohang, Thin Kyaw, Klimkait Thomas, Battegay Manuel, Labhardt Niklaus Daniel,
Project Supporting Lesotho on the way towards the UNAIDS 90-90-90 targets: Operational and clinical research addressing HIV/AIDS care in resource-limited settings
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Original article (peer-reviewed)

Journal BMC Infectious Diseases
Volume (Issue) 18(1)
Page(s) 76 - 76
Title of proceedings BMC Infectious Diseases
DOI 10.1186/s12879-018-2979-y

Open Access

Abstract

Background: The World Health Organization (WHO) recommends viral load (VL) measurement as the preferred monitoring strategy for HIV-infected individuals on antiretroviral therapy (ART) in resource-limited settings. The new WHO guidelines 2016 continue to define virologic failure as two consecutive VL ≥1000 copies/mL (at least 3 months apart) despite good adherence, triggering switch to second-line therapy. However, the threshold of 1000 copies/mL for defining virologic failure is based on low-quality evidence. Observational studies have shown that individuals with low-level viremia (measurable but below 1000 copies/mL) are at increased risk for accumulation of resistance mutations and subsequent virologic failure. The SESOTHO trial assesses a lower threshold for switch to second-line ART in patients with sustained unsuppressed VL. Methods: In this multicenter, parallel-group, open-label, randomized controlled trial conducted in Lesotho, patients on first-line ART with two consecutive unsuppressed VL measurements ≥100 copies/mL, where the second VL is between 100 and 999 copies/mL, will either be switched to second-line ART immediately (intervention group) or not be switched (standard of care, according to WHO guidelines). The primary endpoint is viral resuppression (VL < 50 copies/mL) 9 months after randomization. We will enrol 80 patients, giving us 90% power to detect a difference of 35% in viral resuppression between the groups (assuming two-sided 5% alpha error). For our primary analysis, we will use a modified intention-to-treat set, with those lost to care, death, or crossed over considered failure to resuppress, and using logistic regression models adjusted for the prespecified stratification variables. Discussion: The SESOTHO trial challenges the current WHO guidelines, assessing an alternative, lower VL threshold for patients with unsuppressed VL on first-line ART. This trial will provide data to inform future WHO guidelines on VL thresholds to recommend switch to second-line ART. Trial registration: ClinicalTrials.gov ( NCT03088241 ), registered May 05, 2017.
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