Enrollment in HIV/AIDS clinical trial at UTHCT to evaluate effectiveness and safety of two medications will end soon

Thursday, May 11, 2006

Enrollment in a clinical trial designed to evaluate the effectiveness and safety of two prescription drugs widely used to treat HIV/AIDS will end soon, said Michael Borucki, MD, an associate professor of medicine at UTHSCT.

The University of Texas Health Science Center at Tyler is one of 95 institutions in the United States and the only one in the Tyler area involved in this clinical trial, he said. Enrollment in the clinical trial ends June 5. Pharmaceutical firm GlaxoSmithKline is funding the study.

Its purpose is to compare two well-studied, safe, two-way combination drugs – Epzicom and Truvada – with each other, Dr. Borucki said. GlaxoSmithKline makes Epzicom and Truvada is made by Gilead Sciences.

“It’s a relatively lengthy clinical trial, lasting two years. Many clinical trials involving people with HIV last just six months or a year,” said Dr. Borucki, an infectious disease specialist and principal investigator of the study at UTHSCT.

“Everyone enrolled in this clinical trial receives the preferred protease inhibitor, Kaletra. It’s currently considered the best in its class of protease inhibitors,” he said. Protease inhibitors block the action of a protein that is needed for the HIV virus to reproduce itself. Kaletra also can be taken just once a day, which is much more convenient for patients than having to remember to take it several times a day, Dr. Borucki said.

In addition, participants will receive either Epzicom or Truvada, he said. Neither physicians nor participants will know who is getting which drug.

“Both medications are single tablets taken once a day and have similar safety and benefit profiles. Both are good drugs. The purpose of this study is to determine if one of these is more potent or safer than the other,” Dr. Borucki said.

Participants must be at least 18 years of age, be infected with HIV, and have never received drugs to treat their HIV. Study-related clinic visits, medical evaluations, and investigational medications will be provided at no cost to participants during the 14 months of the study.

One month’s worth of the drugs that make up the standard treatment for HIV/AIDS costs about $1,000, Dr. Borucki said. A month’s supply of the Kaletra-based regimen costs about $1,600.

At the end of 2004, about 415,000 people were living with HIV/AIDS in the United States, according to the Centers for Disease Control and Prevention. Since 1981, when AIDS was first identified, half a million U.S. residents have died from the disease. Approximately 1 million people are currently living with HIV/AIDS in the United States.

Because of drugs developed and tested in clinical trials such as this, many people with HIV/AIDS are able to live a normal and full life, Dr. Borucki said.

“As physicians, we now spend more time worrying about the patients’ blood pressure, blood sugar levels, etc., than on their HIV/AIDS,” he said. Most patients take just two to four pills daily to control their disease.

“The improvements in HIV care are one of the marvels of scientific discovery, even compared with the treatment patients received just a few years ago. We have a number of medications that can be taken once daily. And the safety profile of these newer medications is much better than where we were five or six years ago,” Dr. Borucki said.

For more information about this study, call the Center for Clinical Research at (903) 877-7753.

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