Expanded Access Programs for Investigational Antiretroviral Drugs to Community Health Centers

CDN was funded to implement expanded access/compassionate use programs at community health centers serving low income and minority patients. An expanded access program is a way of making an investigational drug available to patients without other treatment options, once basic requirements for safety and efficacy have been established, prior to the registration and governmental approval of a new drug by the U.S. Food and Drug Administration (FDA). Patients who participate in expanded access programs have previously exhausted the benefits of approved therapies. 

Regulatory requirements for the conduct of clinical research in human subjects are numerous and paperwork- intensive. These requirements exist for the protection of patients from excessive risk and to insure the ethical conduct of research, as well as to assure that all subjects are informed of the risks and benefits of studies in which they participate. The burdens imposed on investigators are substantial and time-consuming. However, unlike regular clinical research programs, clinicians and sites are not paid by the sponsoring pharmaceutical companies to enroll patients in expanded access programs; they receive free medication but no financial support. The HIV/AIDS Program at CDN organized the regulatory documents pertaining to the Expanded Access Program, submited the protocol for IRB review, and assisted the clinicians at its member sites with implementation so that no patient was denied access to new therapies simply because of the setting where he or she receives health care. Clinicians at CDN sites were (and are) anxious to be able to provide all of these investigational drugs to their patients in an effort to arrest the progression of HIV disease that is otherwise inevitable. Medications supplied through expanded access programs must not be restricted to patients seen at major academic medical centers, which already have greater resources for coping with regulatory requirements.

In the first 12 months, expanded access programs for Sustiva, Preveon, Abacavir, Amprenavir, Ritonavir, and Tenofovir were approved by the CDN IRB, and approximately 170 patients were enrolled and received medication at 8 Community Health Centers.