Project Coordinator: Michael Hoelscher
Institution: Ludwig-Maximilians Universitat Munchen (Germany)
Target disease: HIV/AIDS
African countries involved: Cameroon, Cote d’ Ivoire, Ghana, Senegal and Tanzania
Budget: € 2,227,379
Duration of the project: October 2011-June 2013

The main objective of the study is to confirm viral suppression of Fozivudine based antiretroviral regimen after 24 weeks of treatment in non subtype B HIV-1 infected individuals from Africa. The expected target dose is 800 mg OD which will be controlled by an 800 mg BD treatment arm as well as two higher FZD treatment arms (1200 mg/day) in an OD and BD regimen. It will also describe clinical and laboratory adverse events between different FZD treatment arms and to compare FZD outcome with a standard AZT treatment. This first proof of concept study is not powered to evaluate a non inferiority concept between AZT and FZD treatment arms although comparative analyses will be performed. A non-inferiority endpoint will be the primary objective for a second AZT/FZD comparative trial as outlined in the FATI study strategy (section 2.8). Capacity will be built in trials of participating African countries. In addition, the FATI network and trial consortium will be strengthened.