Swift Action Keeps HIV Study on Track

Case Study

PPD managed a randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability and safety of a study drug as part of an antiretroviral (ART), including a study drug and an investigator-selected optimized background regimen in HIV-1 infected patients with limited treatment options. The Phase III study involved 615 patients around the globe, including 32 sites in seven Latin American countries. PPD provided monitoring and regulatory affairs services to investigate the study treatment’s efficacy and safety in patients who took two study drugs compared to a treatment that included only one study drug. The study had a 17-month timeline from startup to database lock.

The project experienced significant startup delays in Brazil resulting from changes in the clinical research regulations at the time. As a result, the nine Brazilian sites were initiated into the study only one to two months prior to the end of the recruitment period.

PPD quickly and effectively navigated that challenge by encouraging the sites to have all their potential subjects pre-identified and waiting to be screened as soon as the site initiation visit was complete. As a result, within one to two months, 494 patients were screened and 236 were enrolled in Brazil alone, keeping the client’s program moving swiftly.