Introduction: Cotrimoxazole (CTX) prophylaxis is recommended by theWorld Health Organisation for HIV infected\npersons. However, once HIV infected patients have commenced ART in resource limited settings, the benefits\nof continued CTX prophylaxis are not known. The few studies that investigated the safety of discontinuing CTX\nprophylaxis in these settings had limitations due to their design.\nMaterials and methods: COSTOP is a randomised double blind placebo controlled non-inferiority trial among HIV\ninfected Ugandan adults stabilised on anti-retroviral treatment (ART). Participants with CD4 count of 250 or\nmore cells/mm3 are randomised to two arms: the intervention arm in which CTX is discontinued and the control\narminwhich CTX prophylaxis is continued. The study aims to assesswhether the intervention regimen is not inferior,\nwith respect to the incidence of pre-defined CTX-preventable events, to the control regimen and superior\nwith respect to the incidence of haematological adverse events.\nDiscussion: Studies that have previously evaluated the safety of discontinuing CTX prophylaxis among HIV infected\nadults in resource limited settings have provided moderate to low quality evidence owing in part to methodological\nlimitations. COSTOP is designed and conducted with sufficient rigour to answer this question. The results\nof the trial will assist in guiding policy recommendations
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