AEGiS-ATN: T-20: New Trial Enrolling, 9 U.S. Cities

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

T-20: New Trial Enrolling, 9 U.S. Cities

AIDS TREATMENT NEWS Issue #300, August 7, 1998
John S. James

On July 30 Trimeris, Inc. announced a trial of T-20, an experimental drug based on an important new approach to antiretroviral treatment. This study, called TRI-003, will enroll up to 78 volunteers at 11 sites in 9 U.S. cities. It will be relatively easy to qualify for entry, since volunteers can be on any stable antiretroviral regimen (or on none at all)--and there are no exclusions for previous use of any antiretrovirals. A viral load of at least 5,000 is required (so that antiretroviral activity of the drug can be measured), and there are some other entry criteria.

T-20 is a synthetic 36-amino-acid peptide which is identical to part of the HIV virion itself; it remains outside human cells and blocks a specific step in the process by which HIV enters new cells (see AIDS TREATMENT NEWS issue #293, April 17, 1998; also #279, September 19, 1997). In a previous human trial T-20 caused a very rapid drop in viral load, with no known adverse effects from the drug. But that early test was limited, because the largest and most effective dose was tested in only four patients; also, T-20 was injected twice a day, an inefficient means of delivery. The new trial will test continuous administration of T-20 by subcutaneous infusion, using a small, pager-size pump, developed by MiniMed Inc., which is currently in widespread use for delivering insulin to diabetics.

The new trial will run for 28 days; its purpose is to learn more about the antiretroviral activity, safety, and plasma pharmacokinetics of T-20. Longer tests will begin after more has been learned about dosage, and after long-term animal safety data has been obtained from ongoing tests. According to Trimeris, volunteers who achieve sustained HIV suppression on TRI-003 will be eligible for another T-20 study which will explore long-term use.

TRI-003 replaces TRI-002, a smaller trial announced June 25. TRI-002 would have required indinavir failure as an entry condition, and also required three particular antiretrovirals to be used in combination with T-20.

Comment

Trimeris changed its study plans after discussions with the trial investigators, community advocates including this writer, and the FDA. We believe that the specific drug requirements of earlier designs would have created serious recruiting, adherence, and other problems, for no purpose. Since T-20 has a completely different mechanism of action than any other antiretroviral in human use, all exclusions for prior or concurrent treatments are unnecessary; what the trial does need is treatment stability, so that the effects of T-20 on viral load can be determined. The TRI-003 design got it right.

One theoretical concern about volunteering for this study is that since so little is now known about how to use T-20, it is possible that doses tested will be too low to fully suppress HIV, which could lead to the development of viral resistance and prevent volunteers from benefiting from T-20 later. Although this risk appears to be small, resistant virus has been created in laboratory cultures. Volunteers and their physicians will have access to viral load results during TRI-003.

Also, the earlier trial found a very rapid drop of viral load with an adequate T-20 dose--perhaps even faster with T-20 alone than with the combination antiretrovirals currently in use. This rapid decline of virus, plus the avoidance of most of the adherence and absorption variability of oral drugs, may reduce the risk of viral resistance. And even if T-20 resistance did occur, there would almost certainly be no cross resistance with any other antiretroviral in human use.

For More Information

For information about volunteering for this trial, call the study coordinator at a site near you (the "contact" listed below). The trial locations are listed alphabetically by city (New York and San Francisco each have two sites). Note that each site cannot begin the trial until it has been approved by the local IRB (institutional review board). But volunteers can call now for more information, and to begin the process or at least get on a waiting list.

Birmingham: University of Alabama. Principal investigator: Michael Kilby, M.D. Contact: Leslie Alldredge, 205-975-9128.

Boston: Community Research Initiative of New England. Principal investigator: Cal Cohen, M.D. Contact: Ruth Cooper, 617-566-4004 ext. 49.

Chapel Hill: University of North Carolina. Principal investigator: Joseph J. Eron, M.D. Contact: Limh Ngo, 919- 966-6712.

Chicago: Northwestern University. Principal investigator: Robert Murphy, M.D. Contact: Joyce Drury, R.N., 312-908-7873.

Houston: University of Texas. Principal investigator: Roberto Arduino, M.D. Contact: Hilda Cuervo, 713-500-6751.

Los Angeles: UCLA. Principal investigator: Margrit Carlson, M.D. Contact: Christine MacNaughton, 310-206-6414.

Maitland, Florida: Central Florida Research Initiative. Principal investigator: C. Jeffrey Goodgame, M.D. Contact: Bill Emery, R.N. C.C.R.C., 407-647-3960.

New York City: Bentley-Salick Medical Practice. Principal investigator: Ramon Torres, M.D. Contact: Mary Catherine George, 212-414-4624.

New York City: NYU Medical Center. Principal investigator: Fred Valentine, M.D. Contact: Karen Cavanaugh, 212-263-8707.

San Francisco: Quest Clinical Research. Principal investigator: Jacob Lalezari, M.D. Contact: Dr. Lalezari, 415-353-0800.

San Francisco: San Francisco General Hospital. Principal investigator: Paul Volberding, M.D. Contact: Doug Raggett, 415-476-9296 ext. 312.

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