AEGiS-GMHC: TREATMENT BRIEFS: Oral Alpha Interferon Trial Resurrected

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

TREATMENT BRIEFS: Oral Alpha Interferon Trial Resurrected

Treatment Issues; Vol. 9, No. 5 - May 1995
Dave Gilden

The proposed 600-person trial of low dose oral interferon (or LDAI -- Kemron and the like) has gotten a new lease on life after rejection by the Community Programs for Clinical Research on AIDS (CPCRA), which is sponsored by the National Institute for Allergy and Infectious Diseases (NIAID). In January, the CPCRA steering committee decided against the one to two million dollar study for many of the same reasons Treatment Issues criticized the study in May, 1994: lack of scientific rationale for yet another trial, limited interest in communities served by CPCRA sites and inadequate resources to monitor and support non-CPCRA sites. The trial was quickly picked up by NIAID's AIDS Research Advisory Committee (ARAC), however. ARAC voted to fund the LDAI trial through the Division of AIDS Treatment Research Initiative, which normally funds university centers to run small trials involving cutting edge technology. The LDAI trial is scheduled to begin recruiting participants this summer.

NIAID spokesperson Greg Folkers defended resurrection of the study, saying, "If you're a doctor in southwest Washington and a patient comes in and says that LDAI is helping all my friends, what do you tell him?" (Most of the people interested in LDAI are African-Americans from communities like the one Folkers cites.)

But Marty Delaney, founder of Project Inform in San Francisco and a member of the ARAC board, dissented vigorously from that body's decision. "We're talking about a time when there are cutbacks in research, and this flies in the face of scientific procedure. The study design won't enable them to find what they want to find and will go on at a bunch of sites that are inexperienced in clinical trials."

Among the trial sites are King Drew Medical Center in Los Angeles and the Nation of Islam-associated Abundant Life Clinics in Washington, D.C. and New York City, whose physicians have been some of the strongest champions of LDAI. Although they claim to have observed symptomatic improvements in HIV-positive patients taking LDAI, several large trials have found no effect from the drug.

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Copyright © 1995 - Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, Inc. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011 fredg@gmhc.org http://www.gmhc.org

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