June 6, 1997 A combination therapy of stavudine (d4T), didanosine (ddI) and indinavir was well-tolerated in a study of HIV-infected children.
The study, conducted by Dr. Mark Kline, associate professor of pediatrics at Baylor College of Medicine in Houston, demonstrated that the drug combination was safe in a small group of symptomatic children.
"No child required either a dose reduction or interruption of therapy," said Kline. "In addition, there were marked changes in CD4 lymphocyte counts and blood HIV RNA concentrations, which suggests that there is potent antiviral activity."
The study evaluated the pharmacokinetics, tolerance, safety, immunologic effects, and antiviral activity of the combination therapy in 12 children, ages 4 to 13.
The children were assessed every four weeks for a period of 24 weeks.
All of the children had been treated previously with nucleoside antiretroviral agents including AZT, ddI and/or d4T.
"There was no obvious adverse interaction between d4T, ddI and indinavir when given in combination," Kline said. "Combination therapy produced impressive decreases in virus load in the body, and CD4 lymphocyte counts increased dramatically, suggesting improvement in the health of the patients' immune systems."
In addition, Kline found substantial amounts of indinavir in cerebrospinal fluid and an absence of HIV RNA, indicating there were antiviral effects within the central nervous system. Many HIV-infected children experience neurologic and developmental problems as a result of HIV's effects on the central nervous system. The research was presented last month at the the annual meeting of the Pediatric Academic Societies in Washington, DC.
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