Treatment Review No. 12; June 1994

There are several protease inhibitor type drugs being tested. Each one is made by a different drug company. The fact that many companies are testing this drug means that scientists are hopeful that one of them will work. A few of the people in earlier studies of the Merck protease inhibitor have had increases in T4 cells from 50 to over 200, although it is not known whether this rise in T4 cells means that the immune system is working better. In addition, the first studies of the drug show that it can reduce the amount of virus that can be measured in the blood. This may mean that the drug can help people with low T4 cells, but it may also be a random occurrence. Additional studies, like this one, will help to determine whether this drug actually works.

It may be difficult to find all the needed participants for this study because of the entry criteria. To be a part of this study you must have less than 500 T4 cells, and have less than 2 weeks of AZT use. But it is okay if you have used ddI, ddC or d4T already. It doesn't matter how long you have been on any of those drugs, if you have. Also, you cannot be positive for hepatitis C antibodies, hepatitis B surface antigens, or have serious liver problems. Liver function tests must be less than two times the normal level.

If you decide to participate in this study, you will receive the protease inhibitor, or the protease inhibitor with AZT, or AZT alone. After you have completed the 24 weeks of the trial, you will be given whatever treatment shows the most benefit. Participants must visit the study site once a week for the first four weeks, then once a month for three months. This study is being done in Philadelphia. Travel costs for New Yorkers will be partially paid for.

There are several other protease inhibitor studies that are scheduled to begin fairly soon. It is likely that people who have already been in a study of any protease inhibitor will not be allowed to join a new one. Then again, it is impossible to get a protease inhibitor outside of a clinical trial.

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