Background The coverage of Artemisinin-based Combination Therapies (ACTs) for treatment of malaria and antiretroviral therapy (ART) is increasing rapidly in Sub-Saharan Africa. Because of the geographical overlap in areas of high malaria and HIV prevalence, HIV-infected people receiving ART may become malaria-infected and will need ACTs.

However, few studies have assessed the safety and efficacy of administering ACTs in people taking ART. The interactions might lead to high ACT drug levels which might cause toxicity or low drug levels which might adversely affect malaria parasite clearance, thereby fuelling resistance.

Methods We conducted a phase IIIb single arm (non-comparative), open label clinical trial. We enrolled and followed up 155 patients at St. Paul's Hospital in Nchelenge district of Zambia. The patients were enrolled in the study after they consented to participate and met strict inclusion and exclusion criteria.

Results Patient enrolment was completed in September 2015. The results of this study are currently being analysed.

Conclusions Data on the safety and efficacy of ACTs in people taking different types of ART are lacking since previous regulatory trials have systematically excluded HIV-positive people, including those receiving ART. Thus, the results of our study will assist in the following ways: determine whether HIV-infected individuals receiving specific types of ART require a specific type of ACTs, inform clinical practitioners about what sort of adverse events they should expect and monitor in people taking different combinations of ACTs and ARTs, and provide evidence-based recommendations to the WHO and National Malaria Control Programmes on safe and effective ACTs that can be used in patients' EFV-based regimen. This study was part of a multicentre trial including centres in Malawi and Mozambique.