1592 Adult Compassionate-Use Program Announced
As this issue went to press, we received an announcement of the open-label protocol for 1592 for adults (the program for children was previously announced; see AIDS Treatment News #275). The number of patients who can enroll will be seriously restricted because of limited drug supply, and limited human experience with the drug. Also, the complete list of sites for the adult program is not yet available -- and many of the sites are not ready at this time, because they still need IRB approval. A central IRB is in place for those sites that need one.
To be eligible for the 1592 open-label adult program (Protocol CNAA/B3008), persons must be at least 13 years old, have a CD4 count under 100 and viral load at least 30,000 copies "within 60 days of registration and while on currently acceptable combination regimens," have been treated with at least two nucleoside reverse transcriptase inhibitors and one protease inhibitor, or not be receiving treatment due to intolerance to at least two different regimens, one of which contains a protease inhibitor (and be intolerant to at least one nucleoside reverse transcriptase inhibitor and one protease inhibitor). Also they must not qualify for an enrolling study of 1592.
There are other exclusion criteria, the most important of which seem to be pregnant women or women who are breastfeeding, or "patients with hepatic failure evident by grade 3 or 4 hyperbilirubinemia and AST >5 x upper limits of normal." 1592 should be administered "as part of a combination antiretroviral regimen, including other antiretroviral agents which the patient has never received," but otherwise the patient "should take as few concurrent medications as medically feasible." The antiretrovirals used in the combination may include those from other compassionate use programs, if approved by both Glaxo Wellcome and the other company.
Physicians interested in enrolling patients should call 800/501-4672.
