MAC (MAI) Clarithromycin "Open Trial" Announced

Persons with mycobacterium avium complex (MAC, also called MAI) may now qualify for clarithromycin treatment through an "open trial" protocol being run by Abbott Laboratories. Clarithromycin, the most important new treatment for MAC, is also available by importation from countries where it has been approved. The advantage of the Abbott program is that there is no cost to the patient for the drug, or for the laboratory tests required for the protocol. The open trial also assures consistent medical monitoring.

Who is Eligible?

The entry criteria for this clarithromycin open trial are:

* Patients must be HIV-positive;

* They must have a lab slip documenting a positive MAC
culture;

* They must usually be age 12 years or older; however,
younger children may be accepted after case-by-case medical
review.

* Women usually need a negative pregnancy test; pregnant
women, however, might still be accepted after medical
review.

* Patients must give informed consent.

Three visits are required in the first 12 weeks for laboratory tests: blood chemistry, and MAC culture. After 12 weeks, in the maintenance phase of the protocol, visits are required every three months. While Abbott provides the drug and tests for free, it will not reimburse for cost of the office visit or associated expenses such as transportation; these are the responsibility of the patient. Other treatments for MAC must be discontinued during the first 12 weeks; later, treatment can be adjusted under guidelines given to the physicians.

Note that there are ongoing formal trials of clarithromycin for both pediatric and adult AIDS-associated MAC. Some patients asking to join the open-trial program may be referred to one of these.

What Physicians Must Do

While some paperwork is necessary to meet FDA requirements, Abbott Laboratories has done everything possible to minimize it -- running an information center staffed by people trained to help, and even filling out all except site-specific information in FDA forms.

IRB (Institutional Review Board) approval is required. If the physician's institution does not have an IRB, Abbott has contracted with an independent IRB to meet the requirements. If the physician does have a regular IRB, it must be used; it cannot be circumvented by Abbott's.

A minimum of five documents is required:

* A curriculum vitae for the physician (or for the principal
investigator and sub-investigators);

* A one-page FDA form;

* The informed consent form, including physician's name and
phone number;

* A letter from the IRB stating that it has reviewed and
approved the protocol and informed consent; and

* Two pages in the protocol signed by the physician and
returned.

Medicine is dispensed on a per-patient basis, within 48 hours when patient first enters the study, later within 24 hours.

Abbott strongly encourages physicians to do the paperwork now, even before they have any patient who qualifies for the program. That way the drug can be available as soon as needed. (The potentially serious delay in this process is the need for IRB approval, which will require a scheduled meeting of the IRB.)

Any physician interested in this program should call Abbott's Clarithromycin Information Center, which can be reached through 800/688-9118, Monday through Friday between 9 a.m. and 9 p.m. Eastern time; physicians will immediately be transferred to the correct desk. The Information Center will mail a packet containing instructions and all necessary forms to any physician who wants one.

Patients also can call this toll-free number for more information about the program.