A multicenter study of low-dose oral alpha interferon (LDOAI) therapy closed June 13, 1997, because too few HIV-infected patients enrolled and remained in the study to enable investigators to answer the study questions. The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), was designed to determine if LDOAI therapy was effective in alleviating symptoms associated with AIDS.
LDOAI therapy has been used in the United States, particularly in African American communities, based on reports that it reduces HIV-related symptoms, such as weight loss and the severity of opportunistic infections associated with HIV. Several clinical trials have shown that LDOAI has no direct effect on HIV -- either in fighting HIV or in improving the immune systems of those infected.
Several important public health issues surrounded the use of LDOAI, including concern that patients were choosing to use LDOAI in place of therapies known to be effective. Therefore, the NIAID AIDS Research Advisory Committee (ARAC) and the National Medical Association recommended that the NIAID conduct a carefully designed clinical trial to assess the effects of LDOAI.
The study began in April 1996, after lengthy development and implementation phases that involved the conduct of pilot studies, special packaging of study drug and the establishment of additional sites. It was designed to enroll 560 HIV-infected volunteers at 14 sites and was expected to take 18 months to complete.
However, by May 1997, the study enrolled only 233 patients, and investigators calculated that, at that rate of enrollment, it would not be completed until the year 2000. In addition, a recent analysis of the data showed that more than 20 percent of patients originally enrolled in the study had dropped out. In order to make up for this loss, the sample size would need to be increased. The scientists are reviewing why patients chose to discontinue participation in the study.
Despite all the hard work of investigators, the companies, and the NIAID Division of AIDS, we are unfortunately not going to be able to provide definitive answers to questions about LDOAI's effectiveness in alleviating symptoms associated with HIV," says study chair Jones Kumi, M.D., of the Mercy Specialty Center in Detroit, Mich.
Once it became obvious that the window of opportunity for this study had passed and that it could not be completed within a reasonable time, it was our duty to stop new enrollment," says Jack Killen, M.D., director of the Division of AIDS. "As part of our responsibility for overseeing the conduct of AIDS treatment studies, we have had to close studies on other occasions due to poor accrual and patient drop-out."
Pharmaceutical support for the study was provided by Amarillo Biosciences, Inc., Interferon Sciences, Inc., and Pharma Pacific Management, Pty. LTD. The companies and the study team all concur with this decision.
NIAID, a component of the National Institutes of Health, supports research aimed at preventing, diagnosing and treating illnesses such as AIDS, tuberculosis, asthma and allergies. NIH is an agency of the U.S. Department of Health and Human Services.Prepared by: