Ability to Adjust Plans Brings Success in HIV Study

Case Study

PPD worked on a randomized, controlled, partially blinded Phase IIb dose-finding trial of a study drug in HIV-I infected subjects with documented genotypic evidence of resistance to currently available non-nucleoside reverse transcriptase inhibitors (NNRTIs). The subjects also had at least three primary protease inhibitor (PI) mutations.

In addition, PPD was involved in a substudy to evaluate the pharmacokinetic profile at baseline and at week four of different doses of study drug b.i.d. (“bis in die,” which means twice a day) on top of an individually optimized antiretroviral therapy.

PPD provided project management and clinical monitoring services for the global study, which was originally scheduled to be conducted at 51 sites in the United States and Brazil with a goal to screen 300 patients and enroll 150.

Strong relationships with investigators and sites ensured PPD exceeded enrollment expectations in the United States so the client did not have to open enrollment in Brazil, resulting in significant cost savings. Screening closed five weeks earlier than projected, with a total of 374 patients, 25 percent more than expected. Enrollment ended one week earlier than anticipated, with 199 patients enrolled, exceeding expectations by 32 percent.

While the trial was under way, the client requested that PPD complete all patient data for a data safety monitoring board (DSMB) meeting only two months away. PPD quickly mobilized, allocating and training several additional CRAs to meet the timeline. The client was able to present the week 12 interim analysis data to the FDA, which allowed the client to move forward with Phase III pivotal trials earlier than anticipated.

As a result of the response to the challenges, PPD was awarded the Phase II rollover, extension and the Phase III pivotal trials, which resulted in expedited FDA approval. One client said, “One of the key success factors [was PPD’s] remarkable ability to listen and adjust the plans in line with the changing challenges and priorities over the different project phases.”