Protease Inhibitor Failure Trial: Combination 1592, 141W94, and Efavirenz
Persons with detectable viral load despite treatment with combination therapy which includes a protease inhibitor are receiving a combination of three new antiretrovirals, in a phase II multicenter study organized by Glaxo Wellcome and now being conducted in nine U.S. cities. As this issue of AIDS Treatment News went to press with an announcement, we learned that the trial as originally designed is oversubscribed, although it started recruiting only in November. There has been discussion about possibly expanding the number of patients, but no decision has been made.Volunteers are 13 or older, with viral load over 500 copies despite treatment including a protease inhibitor. They must have been receiving the same protease inhibitor(s) for the most recent 12 weeks and continuing until the start of the study medication. They must not have used 1592, 141W94, or efavirenz (also called SUSTIVA™, or DMP-266) before; also, certain other treatments must not have been used within 30 days. There are other criteria, including no AIDS-defining opportunistic infection or malignancy except Kaposi's sarcoma, and a negative pregnancy test for women.
This is an open-label study, meaning everyone receives the three medications. There is no randomization or control group. The goal is to study the antiviral activity of the drug combination, and also its safety and tolerability, when existing regimens do not fully control the virus.
Each of these drugs has side effects. For each one, rash is the most common reason for which the drug has had to be discontinued.
