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Executive Summary

Approximately 500 patients are currently enrolled in DDI clinical trials, while 6,000 patients are receiving the drug under expanded access protocols, Bristol-Myers Squibb representatives told FDA's Antiviral Drugs Advisory Committee Jan. 30. Despite the large number in the expanded access program, Bristol-Myers indicated that the monthly accrual rates for two of the three DDI clinical trials are in line with projected accrual rates. The company said that it does not believe that patient enrollment has been adversely affected by the expanded access program. The clinical trials currently underway include: a dose-effect study in AZT-intolerant patients (#118); a comparative study against AZT (Burroughs Wellcome's Retrovir) in patients with short-term or no prior treatment with AZT (#116); and a comparative study against AZT in patients with long-term prior AZT treatment (#117). Enrollment in the studies began in October, as did the expanded access program. Another study comparing DDI to AZT in patients suspected of early failure to AZT is just getting underway now. Bristol-Myers Squibb reported that during the period from Dec. 1-Jan. 12, 93 patients enrolled in study #116, falling within the accrual target of 83 to 125 patients a month. Likewise, study #118 enrolled 47 patients during the period, compared to a projected accrual rate of between 40 and 120. However, study #117 fell below the monthly accrual target, enrolling only 49 patients, instead of the anticipated 62 to 125 patients. Study #118 is furthest along in terms of meeting accrual requirements, with 35% of the necessary subjects enrolled. The other two studies have enrolled only 14% of the patients anticipated by the protocols. The expanded access program includes a Treatment IND for AZT-intolerant patients who either do not meet entry criteria for the clinicals or because of geographic location are unable to enter the clinicals as well as an open label study for patients who are deteriorating on AZT. National Institute of Allergy and Infectious Diseases AIDS Program Director Dan Hoth, MD, said that a comparison to AZT trials shows "that we're right at the same zone of accrual." Hoth also noted that "we are not, with perhaps one or two exceptions, seeing any dramatic drop-off in the accrual of other [AIDS Clinical Trial Group] trials." Although the committee did not formally assess the impact of the expanded access program on clinicals, several members suggested that efforts be made to accelerate accrual in the clinicals in order to generate data to determine the drug's safety and efficacy since the expanded access program will not provide such data. "While we are not asked to comment on the desirability of the expanded access..., when I see 10 times as many on the expanded access as on the related trials, that reinforces to me that the trials are too restrictive," committee member Paul Meier, PhD, University of Chicago, said. "We are following a paradigm of clinical trials...inviting us to collect too much data, inviting us to restrict with long lists of eligibility and ineligibility criteria," he continued. "The appropriate contribution to people suffering from this disease is to develop protocols that involve almost all [patients] in programs that will contribute substantially to an understanding of what works and what doesn't work." Echoing Meier's remarks, committee member Monto Ho, MD, University of Pittsburgh, said: "One of the things that I'm a little concerned about is that we really don't know how well these studies are going...Dan Hoth says they are going at the rate of [AZT studies] #016 and #019 -- is that too fast or too slow?" Clinicals "are the most important things that we need," Ho continued. "I think that we've got our objectives turned around a little bit. We should really be asking 'Why are these things going so slow?' We should really set a new objective of monitoring and accelerating those studies that are being done." Ho added that "just the fact that we have 6,000 patients [in the expanded access program] demands a much greater acceleration of velocity of those studies being done."

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