Development of human medicines is a long process that can take up to 10 years or more and usually involves thousands of patients. In June of 1984, the Centers for Disease Control and Prevention (CDC) reported 4918 cases of AIDS in US with 2221 deaths. By November 1984 the number had increased to 6993 reported cases of AIDS with 3342 deaths. Clearly the need for a new medicine was urgent.
Human clinical trials designed to assess the safety of AZT began in mid-1985 and by early 1986, a larger clinical trial designed to assess the efficacy and safety of AZT compared to placebo had begun. By September 1986 an independent monitoring board stopped the trial and recommended that all patients receive AZT after seeing that 16 patients in the placebo group had died, while only one patient in the AZT group died.
The speed at which AZT moved from investigational medicine to approved medicine speaks to the dedication of the myriad people involved – researchers, government officials, people living with HIV and their families. The full regulatory submission to the FDA was made in December 1986 and the medicine was approved as a treatment for HIV in March 1987.
The impact for patients was huge, remembers Marty: “It wasn’t a cure and we’re doing much better today. But it was the first and it gave them hope.”