31 Jan 2013
Staff Writer
Melissa Wylie / Senior Staff Writer
Patrick G. Clay, professor of pharmacotherapy, published research this year from a study testing a new medication that assists in destroying HIV-infected cells.
“This drug takes advantage of the virus’ inability to proofread its replication,” Clay said.
The drug enhances mutations of the virus which increases the likelihood of DNA errors, preventing HIV from copying itself further, Clay said.
“There have been others looking at alternative ways to prevent the virus from making copies of itself,” Clay said. “There are no other drugs that do anything like this.”
How the virus works
Once HIV enters the body, it attacks a type of white blood cell called the T-cell by replicating its own DNA into the healthy cells, Clay said.
T-cells compose the body’s immune system, and as the virus reproduces, a person’s immunity is destroyed.
HIV replicates quickly and sloppily, often accidently killing a cell completely by creating an error in the DNA, Clay said.
Testing methods
Clay was the principal investigator among a six-member research staff at Kansas City University of Medicine and Biosciences. The group assessed the new drug, currently referred to as KP-1461, developed by Koronis Pharmaceuticals Inc.
As the principal investigator, Clay was responsible for deciding how to test the new drug.
Clay said participants were long-time HIV patients who understood that they would not benefit from the drug, but would be aiding HIV research overall.
“The whole purpose was to expose people who have been on every drug out there, to take them off all other medications and put them on this medicine to see how they react,” Clay said.
Participants took a risk because the effects of the drug were completely unknown. Such risks could have included creating a super-virus or killing the patients faster, Clay said.
Charlotte Williams, nurse manager of the study, acted as the lead coordinator during the study.
Williams said the drug is a pioneer medication in HIV medication, but testing and research is at a standstill.
“My understanding is that there have been some stumbling blocks,” Williams said. “It would be a great class of medication to fight off the virus if it proves effective in humans.”
The Centers for Disease Control and Prevention estimates 50,000 people in the U.S. are newly infected with HIV each year.
In 2009, the CDC reported 21,601 deaths of persons diagnosed with HIV.
Stages of development
There are four stages of new drug development. The first two consist of determining the general effects of the drug and then determining the effects of different dosages.
Only stages one and two were completed before the study was stopped due to funding complications.
Clay said representatives are currently in Washington state, where Koronis is based, looking for sponsors to support the third phase of the study.
Phase three will expose half the participants to a set dose of the drug and half to a placebo, Clay said.
Clay has studied HIV since 1995 and the virus’ constant changes in replication techniques make research challenging.
“The frustrating thing about working with HIV for almost 20 years is that the virus always seems to find a way around what we’re trying to do,” Clay said.
Williams said she would like to see the ground-breaking study carry on.
“I hope we continue researching new treatment options for people with HIV,” Williams said. “It’s always exciting to work with Dr. Clay and be on the cutting edge, finding the newest technology.”
