Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention.

BACKGROUND: With 2.5 million new HIV infections per year, effective preventive methods against HIV are urgently needed, especially in sub-Saharan Africa. MDP301 is an ongoing trial of the vaginal microbicide PRO 2000/5 being conducted by the Microbicides Development Programme. The main objective of the trial is to determine the efficacy and safety of 0.5% and 2% concentrations of PRO 2000/5 gel compared to placebo in preventing vaginally acquired HIV infection. METHODS/DESIGN: MDP301 is a multicentre randomised placebo-controlled Phase III trial. The design was informed by pre-trial feasibility and pilot studies. The choice of trial population, assessments and endpoints are discussed along with statistical and ethical considerations. Adaptations to the design were made during the conduct of the trial; these included closing a study arm and changing the timing of the primary endpoint. DISCUSSION: The development of effective microbicide products remains one of the strongest hopes for new biomedical prevention tools. MDP301 is the largest Phase III microbicide trial to date, with 9404 enrolments, and is scheduled for completion in September 2009. Results are expected towards the end of 2009.