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Prof. Dr. med. Niklaus Labhardt

Department of Clinical Research
Profiles & Affiliations

Clinical Trialist, Infectious Diseases and Global Health Specialist

Niklaus Labhardt is a physician certified in Infectious Diseases, Tropical Medicine, and Internal Medicine. He holds a Master in International Health from the Swiss Tropical and Public Health Institute and obtained an assistant professorship from the Swiss National Science Foundation. Since 2022 he has been a full professor at the University of Basel and head of the Division of Clinical Epidemiology of the University and University Hospital Basel. Since 2023 he is Co-Director of the Department of Clinical Research of the University and University Hospital of Basel. The scope of his research entails epidemiological, clinical, diagnostic, and interventional studies on HIV, tuberculosis, COVID-19, arterial hypertension, diabetes, and common mental disorders. His focus is on pragmatic randomized clinical trials in resource-limited settings that aim at impacting health and health care for underserved populations. He does clinical duty as senior staff physician at the Infectious Diseases Clinic of the University Hospital Basel. Niklaus is a regular lecturer at the University of Basel, the Swiss Tropical and Public Health Institute and ETH Zürich. He has been the president of board of the Swiss not-for-profit organization SolidarMed since 2017.

Selected Publications

Brown, Jennifer Anne, Ringera, Isaac Kaumbuthu, Luoga, Ezekiel, Bresser, Moniek, Mothobi, Buoang, Kabundi, Lorraine, Ilunga, Mulume, Mokhele, Kuena, Isaac, Andreas Boy, Tsoaeli, Ntsepiseng, Mbaya, Thomas, Simba, Brenda, Mayogu, Kasasi, Mabula, Elizabeth, Cheleboi, Molisana, Molatelle, Mamello, Kimera, Namvua, Mollel, Getrud Joseph, Sando, David, et al. (2024). Resistance-informed versus empirical management of viraemia in children and adolescents with HIV in Lesotho and Tanzania (GIVE MOVE trial): a multisite, open-label randomised controlled trial [Journal-article]. The Lancet Global Health, 12(8), e1312–e1322. https://doi.org/10.1016/s2214-109x(24)00183-9

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Tschumi, Nadine, Lukau, Blaise, Tlali, Katleho, Motaboli, Lipontso, Kao, Mpho, Kopo, Mathebe, Hänggi, Kathrin, Mokebe, Moleboheng, Naegele, Klaudia, Ayakaka, Irene, Leuzinger, Karoline, Brown, Jennifer A, & Labhardt, Niklaus D. (2024). Emergence of acquired dolutegravir resistance in treatment-experienced people with HIV in Lesotho [Journal-article]. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae185

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Gerber, Felix, Gupta, Ravi, Lejone, Thabo Ishmael, Tahirsylaj, Thesar, Lee, Tristan, Sanchez-Samaniego, Giuliana, Kohler, Maurus, Haldemann, Maria-Inés, Raeber, Fabian, Chitja, Mamakhala, Mathulise, Malebona, Kabi, Thuso, Mokaeane, Mosoetsi, Maphenchane, Malehloa, Molulela, Manthabiseng, Khomolishoele, Makhebe, Mota, Mota, Masike, Sesale, Bane, Matumaole, et al. (2024). Community-based management of arterial hypertension and cardiovascular risk factors by lay village health workers for people with controlled and uncontrolled blood pressure in rural Lesotho: joint protocol for two cluster-randomized trials within the ComBaCaL cohort study (ComBaCaL aHT Twic 1 and ComBaCaL aHT TwiC 2). Trials, 25. https://doi.org/10.1186/s13063-024-08226-2

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Labhardt ND, Brown JA, Sass N, Ford N, & Rosen S. (2023). Treatment Outcomes After Offering Same-Day Initiation of Human Immunodeficiency Virus Treatment-How to Interpret Discrepancies Between Different Studies. Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America, 77(8), 1176–1184. https://doi.org/10.1093/cid/ciad317

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Firima, E., Retselisitsoe, L., Leisa, I., Manthabiseng, M., Sematle, M. P., Bane, M., Khomolishoele, M., Gonzalez, L., Gupta, R., McCrosky, S., Lee, T., Chammartin, F., Leigh, B., Weisser, M., Amstutz, A., Burkard, T., & Labhardt, N. D. (2023). Head-to-head comparison of the WHO STEPwise approach with immediate unattended and delayed unattended automated blood pressure measurements during household-based screening: a diagnostic accuracy study in Lesotho. EClinicalMedicine, 63, 102197. https://doi.org/10.1016/j.eclinm.2023.102197

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Selected Projects & Collaborations

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SaDAPT: Same-day vs Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of TB

Research Networks of the University of Basel  | 2 Project Members

SaDAPT is a randomized controlled trial in Lesotho and Malawi investigating when to start antiretroviral therapy in persons testing positive for HIV and simultaneously showing symptoms of a possible TB infection.

Rapid, if possible same-day initiation (SDI) of antiretroviral therapy (ART) is recommended for all persons living with HIV (PLHIV) without contraindication who are ready to start treatment. A possible contraindication to initiating ART is the presence of an untreated tuberculosis (TB) infection as it increases the risk of TB-associated immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation. In case of TB symptoms (presumptive TB), previous guidelines recommended to postpone ART initiation until investigations for active TB infection have been completed to avoid initiating ART in presence of untreated TB and thus reduce the risk of TB-IRIS. However, the 2021 guidelines of the World Health Organization (WHO) changed to recommending rapid or SDI even in case of TB symptoms without awaiting results of TB diagnostic tests based on the assumption that TB tests often unnecessarily delay ART initiation increasing the risk for pre-ART attrition from care while the clinical relevance of TB-IRIS outside the central nervous system remains unclear. To date, there is no conclusive evidence about whether SDI of ART or TB test results should be prioritized in PLHIV with presumptive TB.

SaDAPT is a two arm, individually randomized, pragmatic trial comparing two approaches for the timing of ART initiation in PLHIV with presumptive TB (“ART first” versus “TB results first”). PLHIV in Lesotho and Malawi, aged 12 years and older (re)initiating ART who have at least one of TB symptom (cough, fever, night sweats or weight loss) and who do not have signs of meningitis are eligible. Participants in the “ART first” arm will be offered SDI of ART while those in the “TB results first” arm will be offered ART only after results of TB tests are available.

We hypothesize that the “ART first” approach is safe and non-inferior to the “TB results first” approach with regard to HIV viral suppression (<400 copies/ml) six months after enrollment. Secondary outcomes include retention in care and adverse events consistent with TB-IRIS.

Trial registration: The trial has been registered on clinicaltrials.gov (NCT05452616; July 11 2022).