Data and safety monitoring in the Delta trial.

Delta was a randomized trial designed to test whether combinations of zidovudine (AZT) with didanosine (ddI) or zalcitabine (ddC) were more effective than AZT alone for HIV-infected persons. A Data and Safety Monitoring Committee (DSMC) monitored accumulating data. This paper describes the deliberations and recommendations of the DSMC, as clear-cut differences in efficacy gradually emerged during the later stages of the trial.

RCT Entities:   Population Interventions Outcomes