(ATN) Announcement: Baltimore, Boston, Houston, Los Angeles, Milwaukee, Orange, Pawtucket, Philadelphia, San Antonio, San Francisco, and Tampa: Phase II Atevirdine Trial

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(ATN) Announcement: Baltimore, Boston, Houston, Los Angeles, Milwaukee, Orange, Pawtucket, Philadelphia, San Antonio, San Francisco, and Tampa: Phase II Atevirdine Trial

AIDS Treatment News #186 - November 5, 1993


This trial is recruiting persons with T-helper count between 50 and 350, who are currently taking AZT and have been taking it for at least three months before their first dose in this trial, and who are symptomatic -- in category B or C of the CDC 1993 Revised Classification System for HIV Infection (meaning that they have had one or more of a long list of opportunistic infections, which range from less serious ones like thrush and hairy leukoplakia to more serious ones like pneumocystis). Also, volunteers cannot have certain active opportunistic infections or certain other medical conditions, and they cannot have used other experimental non-nucleoside analogs, or protease inhibitors, in previous trials.

Atevirdine (U87201E) is an antiretroviral drug being developed by Upjohn; it is one of the company's "BHAP" [bis(heteroaryl)piperazine] series of compounds. It is a non- nucleoside reverse-transcriptase inhibitor. The main problem with drugs in this class is that HIV rapidly develops resistance to them; however, the drugs are not equivalent, in that resistance develops differently with different ones. A previous clinical trial (ACTG 199) gave ateviridine combined with AZT to a few patients, and did not find resistance after six weeks. Also, in laboratory tests, ateviridine is synergistic with AZT (meaning that the two worked better together than would have been expected by adding together how well they worked separately). It is because of these results that the current trial was judged worth doing.

This trial will last for about one year. Volunteers will be randomly assigned to one of three groups: atevirdine 600 mg per day, atevirdine 200 mg per day, or placebo; meanwhile all volunteers will be using the standard dose of AZT.

Note: Atevirdine (U87201E) should not be confused with delavirdine (U90152S), a later BHAP drug. Compared to atevirdine, delavirdine is effective against HIV in smaller concentrations; however, there is less experience with it in human use. Delavirdine is now in an early trial at the U.S. National Institutes of Health.

For more information about the atevirdine trial, contact the site near you. You can find the phone number and contact person (in one of the cities listed above) by calling the Upjohn AIDS Hotline, 800/432-4702.


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