(ATDN) New protease inhibitor studies


(ATDN) New protease inhibitor studies

Treatment Review #18; April 1995

Several new studies of the Merck protease inhibitor, now called MK-639, are enrolling. To participate in any of these studies you must have blood test results that are within a normal range. The results of a test for indirect bilirubin is especially important. Indirect bilirubin is a common blood test that gives an idea of the health of your liver. Several Network members who would otherwise have been eligible for the MK-639 protease inhibitor study were not enrolled because they had a history of elevated indirect bilirubin tests. Because the only real side effects seen with MK-639 so far have been associated with an increase in indirect bilirubin, the principal investigators of the trial are very closely reviewing everyone who is screened for these studies. If you have a history of elevated indirect bilirubin you will not be allowed to participate. The researchers have been willing to consider people if other blood values were slightly outside of the required range. Retesting sometimes shows that the values do fit the study requirements. The three new MK-639 studies are:

A study of MK-639 and AZT.

Participants will be divided into 3 groups. The first group will take MK-639 alone. The second group takes AZT alone. The third group takes both drugs together. You must be HIV+, 18 years or older, and have a T4 cell count of 50 to 500. You cannot have an active opportunistic infection. Pregnant women or nursing mothers are not allowed. You cannot be intolerant to AZT, or have ever taken any protease inhibitor. You cannot have taken any of the nucleoside analogues - AZT, ddI, ddC, d4T - for more than 2 weeks.

A study of AZT, 3TC and MK-639.

Participants will be divided into three groups. The first takes AZT and 3TC. The second group takes MK-639 alone. The third group takes all three drugs together. To participate you must be HIV+, 18 years or older, and have a T4 cell count of between 50 to 400. You must have taken and tolerated AZT at 600 milligrams for six or more months. Pregnant women and nursing mothers are not allowed. You cannot be hepatitis B surface antigen positive, or have ever taken 3TC or any protease inhibitor. Chronic therapy for an opportunistic infection and other drugs are not allowed. Although this study has already filled up quickly, it's possible that everyone on the list will not qualify . You will be called if this is the case.

A study of AZT, 3TC and MK-639 in people with under 50 T4 cells.

Participants will be divided into three groups. The first group will take AZT and 3TC. The second group will take MK-639. The third group will take all three study drugs together. Those who cannot take AZT or 3TC will be assigned to receive open- label MK-639. To participate in this study, you must be HIV+, 18 years or older, and have taken and tolerated AZT for more than 6 months at the standard dose. Pregnant women and nursing mothers are not allowed. You cannot be hepatitis B surface antigen positive, or have ever taken 3TC or a protease inhibitor. Ongoing therapy for an opportunistic infection, and other drugs which the study coordinator will go over with you are also not allowed. This trial is not expected to start before June. You may be able to get on a waiting list now.


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This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1995. AEGIS.