Effect of high-intensity versus low-intensity praziquantel treatment on HIV disease progression in HIV and Schistosoma mansoni co-infected patients: a randomised controlled trial

<ns4:p><ns4:bold>Background: </ns4:bold>It has been hypothesised that <ns4:italic>Schistosoma</ns4:italic> co-infection exacerbates HIV progression, and hence anthelminthic intervention in co-infected individuals will delay it. We evaluated effects of high-intensity versus low-intensity praziquantel treatment of schistosomiasis on HIV disease progression among co-infected patients from fishing populations around Lake Victoria, Uganda.</ns4:p><ns4:p> <ns4:bold>Methods</ns4:bold>: Between August 2012 and September 2015, we conducted an open-label randomised, controlled trial. Adults, antiretroviral therapy-naïve, CD4 counts ≥350 cells/μl, HIV and <ns4:italic>S. mansoni </ns4:italic>co-infected, were randomised 1:1 to praziquantel (40mg/kg) given quarterly (starting at enrolment) or annually (starting 12 weeks after enrolment; such that low-intensity participants were still untreated when sampled at 12 weeks). A non-randomised HIV-positive <ns4:italic>S. mansoni-</ns4:italic>negative comparison group was recruited. The primary outcome was mean change in plasma viral load at 12 and 60 weeks.</ns4:p><ns4:p> <ns4:bold>Results:</ns4:bold> In total 363 participants (high-intensity 113, low-intensity 113, comparison group 137) were recruited; 96 (85.0%), 97 (85.8%) and 107 (78.1%) completed 60 weeks of follow up, respectively. Adjusting for baseline age and viral load, the geometric mean ratio (aGMR [95%CI]) viral load for high-intensity vs low-intensity groups at 12 weeks was 0.90 [0.65, 1.25] p=0.55 and at 60 weeks 1.88 [0.78, 4.53] p=0.16. Results in the comparison group were similar to trial arms. High-intensity, compared to low-intensity, treatment resulted in substantially lower<ns4:italic> S. mansoni</ns4:italic> prevalence at all follow up visits (p&lt;0.05).</ns4:p><ns4:p> <ns4:bold>Conclusions:</ns4:bold> In communities with a high burden of both <ns4:italic>S. mansoni </ns4:italic>and HIV infection, high-intensity treatment of <ns4:italic>S. mansoni </ns4:italic>does not delay HIV progression despite relevant benefit for parasite clearance.</ns4:p><ns4:p> <ns4:bold>Trial registration: </ns4:bold><ns4:ext-link xmlns:ns3="http://www.w3.org/1999/xlink" ext-link-type="uri" ns3:href="http://www.isrctn.com/ISRCTN15371662">ISRCTN15371662</ns4:ext-link> (17/11/2016)</ns4:p>