T-20: 5-Drug Combination Trial for Heavily Treated NNRTI- Naive Patients Now Recruiting

Central Florida; Atlanta; Los Angeles; New York City; Palm Springs; Pittsburgh; San Diego; San Francisco; St. Louis

T-20 is an antiretroviral that works entirely differently than any approved drug, and seems to have few side effects. It may be important in improving the treatment options available after failure of other antiretroviral combinations.

A trial of T-20 in combination with four approved antiretrovirals is now recruiting in seven U.S. cities. Volunteers must have failed at least one regimen containing a protease inhibitor, and must not have taken an NNRTI--nevirapine, delavirdine, or efavirenz.

All volunteers will receive the following four drugs: abacavir (Ziagen(tm)), amprenavir (Agenerase(tm)), ritonavir (Norvir(r), low dose, 200 mg BID), and efavirenz (Sustiva(tm)). Additionally, the volunteers will be randomly assigned to four groups: no T-20, 50 mg twice daily, 75 mg twice daily, or 100 mg twice daily. Seventeen volunteers will be assigned to each group, for a total of 68 in the trial. (After four weeks, the control group will be able to add compassionate-use T-20 if their viral load has not dropped by at least one log, or gone negative, by that time.)

The T-20 will be self-administered by subcutaneous injection. The infusion pumps used in previous T-20 experiments now appear to be unnecessary for this drug.

This trial will last for a total of one year, including a 16-week treatment period and a 32-week treatment extension.

For more information, call Trimeris, Inc., 919-419-6050, and tell the receptionist that you are calling for information about the T-20-206 trial.

[In the San Francisco area, you can either call Trimeris, or call the sites directly: either Quest Clinical Research (investigator Jay Lalezari, M.D.), coordinator Eileen Glutzer, 415-353-0800; or ViRx, Inc. (investigator Steven Becker, M.D.), recruiter Debbie Hildebrandt, 415-474-4440 x226 (if voicemail, either leave message or enter '0' for the operator). For any other site, call the Trimeris number, above.]


Notes:

(1) AIDS Treatment News anticipates that important new information about T-20 will be released at the upcoming ICAAC conference (Inter-Science Conference on Antimicrobial Agents and Chemotherapy), September 26-29 in San Francisco.

(2) The developer of T-20, Trimeris, Inc., is also beginning a trial of a related drug, T-1249, which may be more potent and has a different resistance profile. But the T-1249 trial is open to entirely different patients, with much less antiretroviral treatment experience.

(3) On July 12, 1999 Trimeris announced an agreement with Hoffmann-La Roche "for the full-scale clinical testing and development of Trimeris's two novel anti-HIV fusion inhibitors, T-20 and T-1249."