WASHINGTON, Nov 6, 2006 (AFP) - A genetically altered AIDS retrovirus that impairs the replication of the HIV virus has shown encouraging results in a small clinical trial, US researchers said in a paper published Monday.
Five advanced AIDS patients unresponsive to at least two antiretroviral treatments experienced decreases in viral load and an increase in white blood cell count that boosts the immune system's response to bacterial, viral and fungal infection, the scientists said.
Normally, the CD4 T white blood cell count in most HIV positive patients drops off year by year.
Published in Monday's issue of the Proceedings of the National Academy of Sciences and conducted at the University of Pennsylvania School of Medicine, the study shows for the first time that a genetically altered virus can be used in humans without any risk, the researchers said.
The results from the clinical trial "are encouraging -- particularly since these are late-stage patients -- and demonstrates that gene therapy has the potential to treat HIV and other serious human diseases," said the study's senior author, Carl June.
The VRX496 virus, made by the VIRxSYS Corporation of Gaithersburg, Maryland, was genetically altered to serve as a Trojan Horse to carry genetic material that inhibits HIV replication.
"The goal of this phase I trial was safety and feasibility and the results established that," June said. "But the results also hint at something much more."
Co-author Bruce Levine struck a cautious tone. "Just because this has produced encouraging results in one or two patients, doesn't mean it will work for everyone.
"We have much work to do," Levine said, noting that the five patients in the study will be followed for 15 years.
A second, phase II clinical trial is under way with AIDS patients whose virus is well controlled by existing anti-retroviral drugs.
Gene therapy, in general, has for now shown to be promising only in a small number of patients and sometimes has had terrible side effects causing leukemia in some patients and even death in one volunteer in 1999.
Research with genetically altered AIDS viruses are financed in part by the federal National Institutes of Health.
Around 40 million people worldwide are infected with the AIDS virus and 25 million have died from the disease.
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