The investigational anti-HIV protease inhibitor
amprenavir (Agenerase), formerly known as 141W94, is now available to
patients who have not responded to current protease
inhibitor-containing regimens through a novel early access program.
The program will provide patients and physicians with more protocol
options than standard expanded access drug programs previously have offered.
Three Options Available
The early access program for amprenavir was opened to enrollment of
patients on September 21 and will include three options for obtaining
One option will be to enroll in an open-label clinical trial to
determine the effect of amprenavir on lipid metabolism
(hyperlipidemia and lipodystrophy) in subjects who are experiencing
these adverse effects and are responding to current antiretroviral therapy.
A second option will be to enroll in an open-label clinical trial
that will evaluate amprenavir or amprenavir combined with a second
protease inhibitor in multidrug regimens for patients who have not
responded to a protease-containing combination.
A third option is for patients who are not responding to their
current therapies and need amprenavir to try to create a viable
treatment regimen to meet their individual needs.
Regardless of which option physicians and patients opt for, patients
need to have received prior treatment with at least one protease
inhibitor in addition to fulfilling other standard criteria. Patients
will also be strongly encouraged to start at least one other anti-HIV
agent that they have not previously used.
It is our hope that making Agenerase available through this
early access program will enable patients who have failed previous
treatment to construct alternative regimens which will fight the
virus, said Lynn Smiley, MD, vice president at Glaxo Wellcome,
the company that is developing amprenavir. Furthermore, by
taking this unique approach to an early access program, we hope to
capture some clinical information regarding Agenerase that might help
guide future antiretroviral treatment decisions.
Patients can be considered for inclusion in the early access program
for amprenavir by having their physicians call 1-800-248-9757.
Details of each option, including enrollment criteria, will be
provided to physicians seeking to enroll patients into the program.
Those patients who qualify for and are enrolled in any one of the
three options will be provided amprenavir free of charge during the
early access program through their physicians and will be counseled
regarding dosing, compliance, and adverse event reporting.
To date, data collected on more than 700 patients receiving
amprenavir have suggested that the drug is generally well tolerated
with few treatment-limiting adverse events. The most commonly
reported adverse events in clinical trials of amprenavir have
included nausea, headache, vomiting, rash and perioral parasthesia.
Amprenavir is dosed twice daily, once in the morning and once in the
evening. In clinical trials, the drug was dosed without regard to
food and water.