AEGiS-PRn: Open Label Access to Investigational Anti-HIV Compound 1529U89 Begins; Expanded Access Program to Begin in 1998

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Open Label Access to Investigational Anti-HIV Compound 1529U89 Begins; Expanded Access Program to Begin in 1998

PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Wednesday, 6 August 1997.

RESEARCH TRIANGLE PARK, N.C., Aug. 6 /PRNewswire/ -- A worldwide open label clinical trial of the investigational anti- HIV drug known as 1592 has begun and is expected to enroll up to 2,400 qualified adult AIDS patients in the United States by year's end. Based on safety data collected in this open label trial, as well as results of ongoing phase II and III clinical studies, a larger international expanded access program for 1592 is expected to begin in 1998. 1592 is a nucleoside analogue reverse transcriptase inhibitor.

Investigators for the open label study are now actively enrolling patients through approximately 65 clinical trial sites located throughout the country. Entry into the study in the United States is being paced at approximately 100 patients per week in order to maximize the existing supply of the drug.

To qualify for enrollment into the adult 1592 open label protocol, patients must have CD4 cell counts of less than 100/mm3 and viral loads greater than 30,000 on a currently acceptable combination regimen, and either have been treated with two nucleoside analogues and a protease inhibitor or are not receiving treatment due to intolerance to prior combination therapy.

Patients can be considered for enrollment in the open label protocol by having their physicians contact the nearest trial site. Physicians can obtain more information regarding trial sites by calling 800-501-4672.

Those patients who qualify and are enrolled into the study by clinical trial investigators will be provided 1592 and will be counseled regarding dosing, compliance and adverse event reporting. 1592 and certain specified laboratory tests will be provided to participants free of charge, however, participants will be responsible for all other costs associated with study visits.

1592 is currently being studied in phase III controlled clinical studies in adults and children. The adult open label study has been developed as a way to provide broader access to the compound for patients who have failed other commercially available treatment regimens and need a new treatment option immediately. It is also hoped that this study will generate important data about the possible usefulness of 1592 in patients with advanced HIV disease.

Preliminary data from early clinical trials of 1592 have suggested that it may have potent antiviral activity. These early data also suggest that it produces few, and generally mild, side effects which include nausea, headache, diarrhea and abdominal pain. The drug also appears to penetrate into the central nervous system and is being studied to determine if it has an effect on HIV -associated neurological disease. To date, approximately 250 patients have received 1592 in various clinical trials

Keywords: HIV; CLINICAL TRIAL; AIDS PATIENTS; TRANSCRIPTASE; CD4; PROTEASE; CLINICAL TRIALS; OPPORTUNISTIC INFECTIONS

Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.

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