Weight gain stopping/switch rules for antiretroviral clinical trials

Venter, WD Francois, Sokhela, Simiso, Calmy, Alexandra, Mkhondwane, Luckyboy, Bosch, Bronwyn, Chandiwana, Nomathemba, Hill, Andrew, Sekwese, Kenly, Mashabane, Nkuli, Pozniak, Anton
et al (show 11 more authors) (2021) Weight gain stopping/switch rules for antiretroviral clinical trials. AIDS, 35 (Suppl ). S183-S188.

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Obesity develops in a substantial number of people initiating and maintaining modern antiretroviral therapy. The comorbidities associated with obesity make significant weight gain and metabolic changes a major consideration in clinical trials studying different regimens' potency and safety. It is as yet unclear what role individual antiretrovirals or classes play in weight gain but the issue is a complex one for clinical trial design, especially when deciding when "too much" weight has been gained, in a context where we do not yet know if switching to alternative regimens will slow, halt or reverse weight gain or metabolic changes. In addition, clinician and trial participant opinion on acceptable weight gain may differ. We offer preliminary guidance for discussion for future antiretroviral clinical trial design.

Item Type: Article
Uncontrolled Keywords: antiretrovirals, clinical trials, obesity, stopping rules, weight gain
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 07 Jun 2022 09:50
Last Modified: 18 Jan 2023 21:00
DOI: 10.1097/QAD.0000000000003092
Open Access URL: http://dx.doi.org/10.1097/QAD.0000000000003092
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3155994