What precautions are being taken to minimize the risk of developing HIV drug resistance for volunteers in the study who become infected with HIV?
The iPrEx study utilizes several safeguards to reduce the risk of drug resistance. Volunteers will be tested for HIV twice before starting the study, and participants will be tested for HIV frequently throughout the study to ensure that, if they do become infected, the study drug is discontinued before resistance can occur. The fact that this study employs a combination of two drugs also makes it less likely that resistance to both drugs will occur. In the unlikely event that a study volunteer develops any resistance to tenofovir/emtricitabine, many therapies would still be fully active to treat their HIV infection, including AZT, nevirapine and efavirenz, and all protease inhibitors, which block HIV replication at a different point than tenofovir/emtricitabine.