Combination therapy with stavudine (d4T) and didanosine (ddI) is safe and well-tolerated in children with advanced HIV infection, according to an NIAID-supported study reported in the June 1996 issue of Pediatrics.
Eight HIV-infected children with CD4+ T cell counts ranging from eight to 553 cells per microliter (UL) of blood received the two-drug therapy during a six-month study period. All children in the study had extensive prior treatment with d4T -- the current study was an extension of a phase I/II study of d4T alone -- and seven of the eight children had previously been treated with AZT.
Mark W. Kline, M.D., and William T. Shearer, M.D., Ph.D., of Baylor College of Medicine in Houston, and colleagues at the University of Minnesota and the Bristol-Myers Squibb Company, found that the combination regimen caused no drug-associated clinical or laboratory adverse events. During the first 12 weeks of the study, plasma levels of HIV RNA decreased in five children and CD4+ T cell counts increased by 20 percent among the three children who had baseline counts above 50 cells per æL.
Based on their findings, the authors call for controlled clinical trials of d4T and ddI in children with less-advanced HIV disease.