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

Autor: Alain Amstutz, Bienvenu Lengo Nsakala, Fiona Vanobberghen, Josephine Muhairwe, Tracy Renée Glass, Beatrice Achieng, Mamorena Sepeka, Katleho Tlali, Lebohang Sao, Kyaw Thin, Thomas Klimkait, Manuel Battegay, Niklaus Daniel Labhardt
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: BMC Infectious Diseases, Vol 18, Iss 1, Pp 1-9 (2018)
Druh dokumentu: article
ISSN: 1471-2334
DOI: 10.1186/s12879-018-2979-y
Popis: 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
Databáze: Directory of Open Access Journals
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