A new multicenter study will examine whether low-dose oral alpha interferon (LDOAI) therapy is effective in reducing the symptoms of AIDS. The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is recruiting 560 people infected with human immunodeficiency virus (HIV), the cause of AIDS.
Jones Kumi, M.D., of the Mercy Speciality Center in Detroit, Mich., serves as the study chair, and Wayne Greaves, M.D. of Howard University in Washington, D.C., is the study co-chair. The study will be conducted at several sites in the United States and will compare three preparations of LDOAI(Alferon LDO, Veldona and Ferimmune).
We believe that NIAID has a strong public health obligation to develop objective scientific data upon which patients and their health care providers can base treatment decisions. We hope that this study will provide such information on the effectiveness of LDOAI in alleviating the symptoms associated with HIV," says Dr. John Killen, director of NIAID's Division of AIDS.
Volunteers will be randomly assigned to one of four arms. All of the participants will receive three compounds. In three of the arms, volunteers will each receive one active compound and two placebos. People in the fourth arm will receive only placebos. While in the study, patients will be allowed to take antiretroviral drugs and therapies against opportunistic infections. Neither the patients nor the doctors will know until the study is completed which substances the patients receive.
To be eligible for the study, called DATRI 022, a person must be HIV infected and in reasonably good health, be 13 years of age or older, and have a CD4+ T cell count between 50 and 350 cells per cubic millimeter of blood. The study is expected to last 18 months: patients will take LDOAI for six months and be followed for an additional six months to assess changes in symptoms.
Pharmaceutical support is being provided by Amarillo Cell Culture, Co., Interferon Sciences, Inc., and Pharma Pacific Management, Pty. LTD.
A list follows of all the sites slated to participate in the study. To obtain contact telephone numbers at these sites, call the AIDS Clinical Trials Information Service at 1-800-TRIALS-A (1-800-874-2572).
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. Public Health Service, part of the U.S. Department of Health and Human Services.
The use of LDOAI in the United States has been controversial, in part because the data about its effectiveness are conflicting and because LDOAI products are sometimes used to exclusion of other HIV therapies with proven value. Large, multicenter, randomized, placebo-controlled trials have shown that LDOAI provides no benefit in fighting HIV, the virus that causes AIDS, or in improving, the immune systems of those infected. Nonetheless, LDOAI products have been used in the United States, particularly in African-American communities, based on reports that these agents have beneficial effects on HIV-related symptoms, weight loss and the severity of opportunistic infections associated with HIV infection.
Because of the important public health issues surrounding its use, the NIAID AIDS Research Advisory Committee (ARAC) requested, in December 1991, that the NIAID undertake a thorough review of all studies involving LDOAI. The results of this review were presented in April 1992.
As LDOAI use increased and its support from prominent African-American physicians expanded, NIAID felt that it was important to better understand the clinical phenomena concerning LDOAI products. In October 1992, NIAID and the National Medical Association (NMA) convened a meeting to solicit advice on how to approach research questions addressing LDOAI.
The end result of this meeting was agreement that a clinical trial be conducted to assess the effects of LDOAI on symptoms caused by HIV. The trial design agreed upon included a placebo arm and blinded randomization so that neither the physician nor the patient would know which product a patient received. The group believed it was important to include all available LDOAI preparations for which proponents have put forth claims of effectiveness.
Based on this recommendation, NIAID agreed to pursue a trial with several LDOAI products. Beginning in July 1993, resources were devoted to developing such a study to be conducted through the NIAID's Terry Beirn Community Programs for Clinical Research on AIDS(CPCRA). However, at its meeting on Jan. 28, 1995, the CPCRA Steering Committee voted against further support and development of the study within the CPCRA.
On Feb. 23, 1995, the ARAC unanimously reaffirmed the need for the Institute to conduct a multicenter study to examine the effects of LDOAI therapy on the symptoms caused by HIV disease. Balancing the concerns expressed by the CPCRA leadership with the identified need for a well-designed objective clinical trial that would provide information upon which to base decisions about treatment, ARAC recommended that NIAID proceed with the study, using the Division of AIDS Treatment Research Initiative (DATRI) for implementation. This would allow interested sites from both the CPCRA and the AIDS Clinical Trials Group (ACTG), as well as others outside of NIAID-supported clinical trials mechanisms, to participate in the trial.Prepared by: