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AIDS Treatment Data Network
(ATDN) New Protease Inhibitor Studies

November 1, 1995
Treatment Review No. 20; November 1995

Protease inhibitors are a new class of anti-HIV drugs. They work by blocking a part of HIV called protease. When protease is blocked, HIV makes copies of itself that can't infect new cells. So far, protease inhibitors appear to be potent anti-HIV drugs. Studies have shown that protease inhibitors can reduce the amount of virus in the blood and increase T4 cell counts. In some cases these drugs have improved T4 cell counts even when they were very low. Several different drug companies are testing different brands of protease inhibitors. Two new protease inhibitor studies are enrolling at Columbia Presbyterian in New York. The protease inhibitor is called saquinavir (also known as Invirase) and is made by a company called Hoffman-La Roche.

For people with T4 cells between 150 and 500 - If you have between 150 and 500 T4 cells, and have not taken anti-HIV drugs before, you may be eligible for this study. The drugs being studied are the protease inhibitor saquinavir in combination with AZT and 3TC. This study last four weeks. All participants can continue taking study medications after the trial is finished.

For people with T4 cells between 100 and 500 - The second trial will study a new soft gelatin capsule formulation of saquinavir. The current hard gelatin capsule formulation is not very well absorbed by the body. It is hoped that the new soft gelatin capsule will be better absorbed. The study will compare the old and new formulations. You must have between 100-500 T cells to be in this study. Previous anti-HIV therapy is allowed. This study lasts four weeks. All participants can continue taking study medications after the trial is finished.

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